[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ViiV Healthcare\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":378},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,51,73,99,127,153,178,205,218,242,272,295,320,336,361],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053226","phase-1-a-study-to-investigate-the-safety-and-pk-of-vh4770359-in-healthy-participants-100053226",false,"NCT07525544","A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants","A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants","Inclusion Criteria:\n\n1. 18 to 55 years old\n2. BMI 18.5-37.0 kg\u002Fm2\n3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant\u002Fbreastfeeding and be of non-childbearing potential.\n\nExclusion Criteria:\n\n1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.\n2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.\n3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and\u002For anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).\n4. A history of or ongoing high-risk behaviors for HIV acquisition.\n5. Use of prohibited medications.\n6. Exclusionary allergies or sensitivities.\n7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.\n8. Exclusionary prior or concurrent clinical study participation.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},214,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.",[28],"HIV Infections",[30,31,32,33,34,35,36,37],"First-Time-in-Human","Safety","Tolerability","Pharmacokinetics","Healthy participants","Human immunodeficiency virus (HIV)","VH4770359 (GSK4770359)","Oral","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2026-05-14",{"date":46,"type":22},"2027-05-05",{"name":48,"class":49},"ViiV Healthcare","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100643152","phase-1-mass-balance-and-absolute-oral-bioavailability-of-14cvh4524184-100643152","NCT07636928","Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184","A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants","Inclusion Criteria:\n\n1. Willing and able to sign the Informed Consent Form (ICF).\n2. Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.\n3. Age: 18 to 55 years, inclusive, at screening.\n4. BMI: 18.0 to 32.0 kg\u002Fm\\^2, inclusive, at screening.\n5. Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration \\>33.4 milli-international units per milliliter (mIU\u002FmL) at screening to confirm menopause.\n6. Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.\n7. Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.\n8. All prescribed medication must have been stopped at least 30 days and \\>5 half-lives prior to admission to the clinical site on Day -1.\n9. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -1. An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -1.\n10. Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.\n11. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.\n12. Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Employee of ICON, the Sponsor, GSK or associated vendors.\n2. History of relevant drug and\u002For food allergies.\n3. History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.\n4. Using tobacco\u002Fnicotine products within 60 days prior to the first study drug administration.\n5. History of alcohol abuse or drug addiction within 5 years prior to screening.\n6. Positive drug and\u002For alcohol screen at screening or admission to the clinical site.\n7. Average intake of more than 24 units of alcohol per week.\n8. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.\n9. Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.\n10. Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)\u002Fmore than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.\n11. Significant and\u002For acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.\n12. Any significant current\u002Fongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and\u002For insomnia\u002Fsleep disturbances and\u002For suicidal ideation, in the opinion of the Investigator.\n13. Unsuitable veins for infusion or blood sampling.\n14. Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.\n15. Irregular defecation pattern.\n16. Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and\u002For significant baseline signs and symptoms.\n17. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.",{"count":59,"type":22},9,[25],"The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.",[28],[64,35],"VH4524184","2026-06-29",{"date":67,"type":42},"2026-07-02",{"date":69,"type":42},"2026-06-04",{"date":71,"type":22},"2026-08-20",{"name":48,"class":49},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100539954","phase-1-first-time-in-human-study-of-long-acting-vh4524184-formulations-100539954","NCT06310551","First Time in Human Study of Long Acting VH4524184 Formulations","A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults","Inclusion Criteria:\n\nAge\n\n1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n\n   Type of Participant and Characteristics\n2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n3. Participants who are negative for SARS-CoV-2, performed on admission\u002Freadmission to the Phase 1 unit, using an approved molecular test (PCR).\n4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.\n\n   Weight\n5. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg\u002Fm\\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \\>32.0 to 37.0 kg\u002Fm\\^2 (inclusive).\n\n   Sex and Contraceptive\u002FBarrier Requirements\n6. Male or female\n\n   1. Male Participants: No restrictions for male participants\n   2. Participants of female sex assigned at birth:\n\n      * A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception.\n      * A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met.\n\n   Informed Consent\n7. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.\n2. Clinically significant abnormal blood pressure as determined by the investigator.\n3. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n4. Breast cancer within the past 10 years.\n5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.\n6. Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.\n7. Underlying skin disease or disorder that would interfere with the administration of study product and\u002For assessment of injection site reactions.\n8. Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of \u002Fsensitivity to any of the study interventions including hyaluronidases.\n9. Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n10. History of seizure.\n11. Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia\u002Fsleep disturbances, at the discretion of the investigator.\n12. Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening.\n13. Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator.\n14. Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and\u002For assessment of ISRs, if they occur.\n15. History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.\n\n    Prior\u002FConcomitant Therapy\n16. Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.\n17. Receipt of any live vaccine(s) or vaccines against SARS-CoV-2 within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing.\n\n    Prior\u002FConcurrent Clinical Study Experience\n18. Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.\n19. Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product before signing of consent (OR screening) any other clinical study.\n20. Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period.\n21. Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU admission and receipt of injectable suspension for injection (SFI) or powder for suspension for injection (PFS) study medication or placebo, or prior participation in study 218803.\n\n    Diagnostic Assessments\n22. eGFR \\\u003C60 mL\u002Fmin or serum creatinine \\>1.1 x ULN.\n23. Hemoglobin \\\u003C12.5 g\u002FdL for men and \\\u003C11 g\u002FdL for women\n24. ALT or AST \\>1.5x upper limit of normal (ULN)\n25. Total bilirubin \\>1.5xULN.\n26. Any significant arrhythmia or ECG finding.\n27. Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination.\n28. Presence of HBsAg and\u002For anti-HBc at Screening or within 3 months prior to first dose of study intervention.\n29. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.\n30. Positive pre-study drug\u002Falcohol screen.\n31. Positive HIV antibody test.\n\n    Other Exclusions\n32. Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \\>14 units for males or \\>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n33. Regular use of known drugs of abuse.\n34. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission.\n35. Sensitivity to the study drug, or components thereof, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.",{"count":81,"type":22},372,[25],"The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.",[28],[31,32,86,87,33,88,89,90],"Parenteral","First Time in Human","Ascending Dose","Multiple Dose","Healthy Adults",{"date":92,"type":42},"2026-06-30",{"date":94,"type":42},"2024-03-21",{"date":96,"type":22},"2028-01-21",{"name":48,"class":49},3,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100641883","phase-3-a-study-to-investigate-cabotegravir-ultra-long-acting-cab-ula-plus-rilpivirine-ultra-long-acting-rpv-ula-in-adults-and-adolescents-with-hiv-who-are-virologically-suppressed-100641883","NCT07650916","A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed","A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART","Inclusion criteria:\n\nPatient Study Participant (PSP) Inclusion criteria:\n\n* Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \\>35 kg.\n* Documented HIV-1 RNA measurements \\\u003C50 copies\u002FmL in the 12 months prior to Screening.\n* HIV-1 RNA \\\u003C50 copies\u002FmL at screening assessment.\n* Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.\n* Any prior switch in therapy must have occurred due to tolerability\u002Fsafety, access to medications, or convenience\u002Fsimplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies\u002FmL).\n\nExclusion criteria:\n\nPatient Study Participant (PSP) Exclusion criteria:\n\n* Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.\n* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.\n* Any history of receiving long-acting therapy for HIV.\n* Previous exposure to CAB and\u002For RPV for treatment or prevention of HIV-1 infection.\n* Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","12 Years",{"count":108,"type":22},564,[110],"PHASE3","This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).",[28],[114,115,116,117,118,31,32],"Cabotegravir","Rilpivirine","HIV","Non-inferiority","Efficacy","NOT_YET_RECRUITING","2026-06-19",{"date":122,"type":42},"2026-06-23",{"date":65,"type":22},{"date":125,"type":22},"2029-09-04",{"name":48,"class":49},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100569481","phase-3-a-study-to-evaluate-the-effectiveness-of-long-acting-la-cabotegravir-cab--rilpivirine-rpv-la-when-given-to-participants-with-detectable-hiv-1-100569481","NCT06694805","A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1","A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)","CROWN","Inclusion Criteria:\n\n* Age\n\n  1\\. Aged \\>=12 years and \\>=35 kg (at the time of obtaining informed consent).\n* Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.\n\n  3.Plasma HIV-1 RNA \\>1 000 c\u002FmL and greater than (\\\u003C) 100 000 c\u002FmL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.\\\u003C1 log10 decrease in HIV-1 RNA or HIV-1 RNA \\>200 c\u002FmL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months.\n\nii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and\u002For limited tolerability, clinically relevant DDIs).\n\nCurrently being treated with an oral ART regimen specific regimen to be recorded at Screening, and willing to continue taking that regimen until approximately 1 week after the Month 6 visit.\n\n* Pregnancy, Sex and Contraceptive\u002FBarrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test at screening and on Day 1.\n* Informed Consent\u002FAssent 6.Informed consent\u002FAssent must be provided as follows:\n\n  1. Adult participants (\\>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and stated in the full study protocol.\n  2. For adolescent participants (12 to \\\u003C18 years of age at screening), the parent(s) or legal guardian must be capable of giving signed informed consent.\n\nExclusion Criteria:\n\n• Medical Conditions\n\n1. HIV-1 Subtype A6, if known from historical result.\n2. Participants who are pregnant, breast\u002Fchest feeding or plan to become pregnant or breast\u002Fchest feed during the study.\n3. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).\n4. Individuals with both HIV and Hepatitis B virus (HBV) will be excluded from participating in studies where they would not be able to receive appropriate therapy for their HBV co-infection and therefore may be at risk of hepatitis B flare. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV.\n5. History of liver cirrhosis with or without hepatitis viral co-infection.\n6. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.\n7. Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).\n8. Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.\n9. History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.\n10. Participants who in the investigator's judgment, pose a significant suicidality risk. Participant's history of suicidal behaviour and\u002For suicidal ideation should be considered when evaluating for suicide risk.\n11. Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and\u002For protocol evaluations or which may compromise the safety of the participant.\n\n    • Prior\u002FConcomitant Therapy\n12. Any previous use of CAB.\n13. Current or anticipated need for chronic anti-coagulants.\n14. Use of concomitant medications which are associated with Torsades de Pointes (TdP).\n15. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.\n16. Treatment with any of the following agents within 28 days of Screening:\n\n    1. radiation therapy;\n    2. cytotoxic chemotherapeutic agents;\n    3. tuberculosis therapy with the exception of isoniazid;\n    4. anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (\\\u003C=325mg);\n    5. immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.\n17. Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational medicinal product (IP).\n18. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.\n\n    • Prior\u002FConcurrent Clinical Study Experience\n19. Participant is currently participating in, or anticipates being selected for, any other interventional study.\n\n    • Diagnostic assessments\n20. Any evidence of viral drug resistance based on the presence of any major RAM to INSTIs or NNRTIs in the Screening result; or, if known, in any historical resistance test result.\n21. Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.\n22. Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.\n23. ALT \\>=5 times ULN or ALT \\>=3×ULN and bilirubin \\>=1.5×ULN (with \\>35% direct bilirubin).\n24. eGFR of \\\u003C30 mL\u002Fmin\u002F1.73 m2 via refitted, race-neutral CKD-EPIcr\\_R method (adult participants) or \\\u003C50 mL\u002Fmin\u002F1.73 m2 using the Bedside Schwartz equation (adolescent participants).\n25. Hemoglobin \\\u003C9.0 g\u002FdL.\n26. Corrected QT interval (QTc \\>450 msec or QTc \\>480 msec for participants with bundle branch block, calculated using ECGs performed in triplicate).\n\n    • Other exclusions\n27. Unwilling to receive injections, or unable to receive gluteal injections.\n28. The participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reaction (ISRs).\n29. Evidence of alcohol or substance use disorder within the previous 12 months, using standard methods for their site, that would interfere with the participant's safety.\n30. Adolescents who are wards of the state or government. To assess any potential impact on participant eligibility with regard to safety, the investigator must refer to the Investigator's brochure (IB) and supplements, approved product labels, and\u002For local prescribing information for detailed information regarding warnings, precautions, contraindications, AEs, drug interactions, and other significant data pertaining to the study drugs.",{"count":136,"type":22},332,[110],"This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.",[28],[141,114,115,142,118,31,143],"HIV Infection","Long-acting","Durability","2026-05-25",{"date":146,"type":42},"2026-05-27",{"date":148,"type":42},"2024-12-02",{"date":150,"type":22},"2028-08-18",{"name":48,"class":49},89,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":50},"100614131","phase-1-a-study-to-investigate-cabotegravir-for-neonates-exposed-to-hiv-1-100614131","NCT07275606","A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1","A Phase 1\u002F2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1","CABNATE","Inclusion Criteria:\n\n* At least 37 weeks gestation at delivery.\n* \\\u003C=10 days of life.\n* Birth weight at least 2 kg.\n* At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis.\n* At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings.\n* Mother is on a Dolutegravir (DTG) based regimen for a minimum of 4 weeks prior to delivery, regardless of maternal viral load.\n* Mother is currently breastfeeding or plans to breastfeed infant.\n* Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide documented informed consent for her and her infant's participation in this study.\n* Mother has confirmed HIV-1 infection based on positive test results from 2 samples collected from 2 separate blood samples. Test results may be obtained from medical records or from testing performed during the study Screening period.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by examining clinician.\n* Known maternal-fetal blood group incompatibility which can result in hemolytic disease of the newborn.\n* Known family history of G6PD deficiency.\n* Prior\u002FConcomitant therapy\n* Mother who has previously received, is receiving, or will be receiving CAB post-partum.\n* Neonate or breastfeeding mother is receiving any disallowed medication.\n* Prior\u002FConcurrent clinical study participation\n* Neonate has exposure to other investigational drugs that might interfere with study intervention metabolism.\n* Diagnostic assessments\n* Mother has known Integrase strand transfer inhibitor (InSTI) resistance.\n* At Entry, neonate with a confirmed, documented positive HIV Nucleic acid amplification test (NAAT) test result.\n* At Screening, neonate has any of the following laboratory test results:\n\n  * Alanine transaminase or Aspartate aminotransferase of more than 2.5 x Upper limit of normal (ULN).\n  * Total bilirubin in range for phototherapy at Entry.\n  * Hemoglobin \\\u003C13.0 g\u002FdL.\n  * Decreased white blood cells Grade 3 or above.\n  * Platelets \\\u003C50 000 cells\u002Fmm3\n  * Creatinine value more than 1.3 the ULN for postnatal age as defined in Division of AIDS (DAIDS)\n  * Albumin Grade 3 or higher.\n  * Direct bilirubin Grade 3 and above.\n* Any other Grade ≥3 event on DAIDS toxicity table\n* Neonates with prior exchange transfusion. Other exclusion criteria\n* Mother or neonate has a condition that, in the site Investigator or designee's opinion, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Neonate is receiving DTG as part of HIV prophylactic regimen. Liver safety exclusion criteria\n* Known maternal hepatitis B infection. Cardiac safety exclusion criteria\n* At screening, QT interval corrected using Fridericia's formula \\>450 msec.","10 Days",{"count":163,"type":22},44,[25,165],"PHASE2","The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.",[28],[114,169,116,31,32,33],"Neonate","2026-05-15",{"date":172,"type":42},"2026-05-19",{"date":174,"type":42},"2026-04-15",{"date":176,"type":22},"2029-10-10",{"name":48,"class":49},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100608514","phase-2-a-phase-2b-study-evaluating-oral-vh4524184-regimens-in-treatment-nave-persons-with-hiv-1-innovate-study-100608514","NCT07202546","A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)","A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of Oral VH4524184 Coadministered With Emtricitabine and Tenofovir Alafenamide in Treatment Naive Viremic Persons With HIV-1 (INNOVATE Study)","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.\n2. Screening CD4+ T-cell count \\>200 cells\u002Fmicrolitre (µL).\n3. Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies\u002Fmillilitre (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.\n4. Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.\n5. Body weight \\>=50.0 kilogram (kg) \\[(110 pounds (lbs)\\] for participants assigned male at birth and \\>=45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg\u002Fm\\^2 (inclusive - applies to males and females).\n6. There are no contraceptive requirements for participants assigned male at birth.\n7. Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding and one of the following conditions applies:\n\n   * Is a Participant of non-childbearing potential (PONCBP);OR Is a Participant of childbearing potential (POCBP) and using a contraceptive method with a failure rate of less than (\\\u003C) 1% prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC\u002FTAF FDC, or through the end of study (if in the control arm and never received VH4524184).\n   * A POCBP must have a negative pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention.\n   * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. Participant with a positive serum test must be excluded.\n8. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Participants who are breastfeeding or plan to breastfeed during the study.\n2. Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and\u002For evidence of recent (within 3 months) documented viremia without antibody production and\u002For evidence of recent (within 3 months) documented seroconversion.\n3. Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease \\[CDC 2014\\], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells\u002FµL are not exclusionary.\n4. Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).\n5. History of cirrhosis with or without viral hepatitis co-infection.\n6. Participants with HCV co-infection will be excluded from the study.\n7. Individuals who are co-infected with HIV and HBV will be excluded Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease.\n8. Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.\n9. Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant's ability to comply with the dosing schedule and\u002For protocol evaluations or which may compromise the safety of the participant.\n10. Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication and normal gastrointestinal anatomy or motility or hepatic and\u002For renal function\n11. Clinically significant CV disease, as defined by history\u002Fevidence of congestive heart failure, symptomatic arrhythmia, angina\u002Fischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.\n12. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.\n13. History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.\n14. Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n15. Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.\n16. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.\n17. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.\n18. Exposure to an approved vaccine within 14 days prior to Day 1.\n19. Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research\n20. Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and\u002For ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1.\n21. Creatinine clearance (eGFR) of \\\u003C60 mL\u002Fmin\u002F1.73 m2 via CKD-EPI race neutral method \\[Delgado, 2021\\].\n22. ALT \\>3 times the upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.\n23. Any Grade 4 laboratory abnormality at screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.\n24. Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.\n25. Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 msec (males) or \\>470 msec (females); \\>480 msec for participants with bundle branch block.",{"count":186,"type":22},150,[165],"This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC\u002FTAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG\u002F3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.",[28],[191,192,193,194,195,64],"Fixed dose combination","Antiretroviral","Antiviral","Naive viremics","Innovate","2026-05-07",{"date":198,"type":42},"2026-05-08",{"date":200,"type":42},"2026-02-11",{"date":202,"type":22},"2028-07-24",{"name":48,"class":49},113,{"id":206,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":26,"conditions":209,"keywords":210,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":217,"locationsCount":4},"100633350",{"count":21,"type":22},[25],[28],[30,31,32,33,34,35,36,37],"2026-04-06",{"date":213,"type":42},"2026-04-13",{"date":215,"type":22},"2026-04-07",{"date":46,"type":22},{"name":48,"class":49},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100623209","phase-3-a-continued-access-study-for-participants-transitioning-from-viiv-healthcare-sponsored-or-viiv-healthcare-collaborative-parent-studies-for-hiv-treatment-100623209","NCT07393659","A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment","A Phase 3b, Open-label, Multicenter, Continued Access Study for Participants Transitioning From ViiV Healthcare Sponsored or ViiV Healthcare Collaborative Parent Studies for HIV Treatment","PATH","Inclusion Criteria:\n\nParticipants are eligible to be included in this study only if all the following criteria apply:\n\n* Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for the parent study (i.e., have not met parent study discontinuation\u002F withdrawal criteria).\n* Participants or legally authorized representative (LAR) who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable appendix and determined by the Investigator.\n* Participant or LAR is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and this protocol. Where applicable, participants must provide written assent.\n\nExclusion Criteria:\n\nParticipants are excluded from participating in this study if the following criterion applies:\n\n• Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant's inclusion in the study.",{"count":227,"type":22},183,[110],"The purpose of this study is to provide continued access to the study treatment for participants from previous ViiV Healthcare studies who are still benefiting from it and do not have local access after completing the parent study. This continued access will also allow further collection of safety data. Eligible participants are those who completed a ViiV Healthcare-sponsored or collaborative parent study and are currently experiencing clinical benefit. The Sponsor will periodically review the study to consider other treatment access options.",[28],[232,233,234],"Human Immunodeficiency Virus (HIV)","Open label","Continued access","2026-01-30",{"date":237,"type":42},"2026-02-06",{"date":198,"type":22},{"date":240,"type":22},"2030-12-30",{"name":48,"class":49},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100526409","phase-3-long-term-follow-up-of-long-acting-cabotegravir-cab-la-for-prep-pre-exposure-prophylaxis-in-participants-at-risk-of-acquiring-hiv-human-immunodeficiency-virus-100526409","NCT06134362","Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)","A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition","PALISADE","Inclusion criteria:\n\nType of participant\n\n1. Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:\n\n   * HPTN 083 open label extension\n   * HPTN 084 open label extension (including pregnancy sub-study)\n\n   Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment.\n\n   Participants who have prematurely withdrawn from prior CAB PrEP studies cannot enroll into this study.\n2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study\u002Fsub-study.\n3. Participants must have nonreactive HIV tests at Screening (rapid test, immunoassay \\[antigen\u002Fantibody\\] test and HIV-1 RNA results must all be available and nonreactive) and Day 1 (at least one of rapid test and immunoassay \\[antigen\u002Fantibody test\\] results must be available and nonreactive). Participants who have one or more reactive or positive HIV test result(s) will not be enrolled, even if subsequent confirmatory testing indicates they are not HIV-infected.\n\n   Sex\n4. Males and Females:\n\n   All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit\u002Frisk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs.\n\n   Females:\n\n   Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options. Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.\n\n   Pregnant participants from the HPTN 084 study are eligible to enroll into this study if they meet all eligibility criteria.\n\n   Informed consent\n5. Participant or caregiver\u002Flegal guardian is able and willing to provide signed informed consent as described in Protocol Section 11.1.5, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Where applicable, participants must provide written assent.\n\nExclusion Criteria:\n\nConcurrent conditions\u002Fmedical history (includes liver function)\n\n1. Participants who are currently enrolled in the eligible studies on the TDF\u002FFTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF\u002FFTC bridging may be enrolled following consultation with the Medical Monitor.\n2. Previous premature discontinuation from IP in the parent study\u002Fsub-study.\n3. ALT \\>5 × ULN; or ALT\\>3 × ULN and bilirubin \\>1.5 × ULN (with \\>35% direct bilirubin) in the screening liver chemistry test result.\n4. Participants with known active hepatitis B infection (as indicated by a positive HBsAg and\u002For quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded.\n5. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).\n6. Known history of cirrhosis with or without viral hepatitis co-infection.\n7. Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) with a compound or device that is not commercially available within 30 days prior to signing informed consent, unless permission from the Medical Monitor is granted.\n8. Presence of or any history of allergy\u002Fsensitivity to the study drug or its components.\n9. Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee.\n10. Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs.\n11. Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications\n12. Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.\n13. Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug: drug interactions with study treatment throughout the entire study period.\n\n    Relevant habits\n14. Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.\n15. Any condition (i(including but not limited to substance use disorder) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.\n\n    Other\n16. Participant has in the last 14 days prior to screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical suspicion of HIV is ruled out with non-reactive results using appropriate HIV tests as per Inclusion Criterion #3.\n17. Participant is a ward of the state (e.g. child in care).",{"count":251,"type":22},3508,[110],"The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.",[28],[116,256,257,114,258,259,260,261,262],"Human Immunodeficiency Virus","CAB LA","Apretude","PrEP","HPTN 083","HPTN 084","DAIDS","2025-12-19",{"date":265,"type":42},"2025-12-22",{"date":267,"type":42},"2024-05-14",{"date":269,"type":22},"2029-01-01",{"name":48,"class":49},34,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":98},"100471437","phase-1-a-study-to-investigate-pharmacokinetics-safety-and-tolerability-of-long-acting-cabotegravir-plus-recombinant-human-hyaluronidase-ph20-in-healthy-adult-participants-100471437","NCT05418868","A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants","A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers","Inclusion Criteria:\n\n* At the time of obtaining informed consent, participants age should be greater than or equal to (\\>=)18 years and less than or equal to (\\\u003C=) 55 years.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Body weight \\>=40 kilogram (kg) and body mass index (BMI) within the range \\>=18 to \\\u003C=32 kilogram per meter square (kg\u002Fm\\^2).\n* Participants who are negative on a single test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction \\[PCR\\] laboratory or point of care test), performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving written informed consent.\n\nExclusion Criteria:\n\n* Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities.\n* History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.\n* Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person\u002Fs in the 14 days prior to inpatient admission.\n* Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody\u002Fantigen test.\n* History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.\n* Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n* Abnormal blood pressure.\n* Evidence of previous myocardial infarction.\n* Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular \\[AV\\] block \\[2nd degree or higher\\], Wolff- Parkinson-White \\[WPW\\] syndrome).\n* Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant.\n* One or more exclusionary values for a screening Electrocardiogram (ECG).\n* Alanine transaminase (ALT) \\>1.5x upper limit of normal (ULN).\n* Bilirubin \\>1.5xULN (isolated bilirubin \\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35 percent \\[%\\]).\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C60 milliliter per minute (mL\u002Fmin) using the Chronic Kidney Disease\n* Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021).\n* Hemoglobin \\\u003C12.5 gram per deciliter (g\u002FdL) for men and \\\u003C11 g\u002FdL for women.\n* Positive pre-study drug\u002Falcohol screen.\n* Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices).\n* Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of \\>14 units for males or \\>7 units for females.\n* Regular use of known drugs of abuse.\n* Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.\n* Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day.\n* History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation, including a known hypersensitivity to hyaluronidases.\n* Current or anticipated need for chronic anti-coagulation therapy.\n* Hereditary coagulation and platelet disorders (e.g., hemophilia or Von Willebrand disease \\[VWD\\]).\n* Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention.\n* Any other clinical condition, behavior or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.\n* Participant who in the investigator's judgment poses a significant suicidality risk. Participant's history of suicidal behavior and\u002For suicidal ideation should be considered when evaluating for suicide risk.",{"count":21,"type":22},[25],"This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg\u002FmL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \\>=400 mg\u002FmL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg\u002FmL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \\>=400 mg\u002FmL with rHuPH20) will not be conducted due to changes in the study design.",[28],[284,285,286,33,31,32],"Cabotegravir (CAB)","Rilpivirine (RPV)","Long-Acting Injection","2025-12-10",{"date":289,"type":42},"2025-12-18",{"date":291,"type":42},"2022-06-14",{"date":293,"type":22},"2027-06-08",{"name":48,"class":49},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100571775","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-vh4011499-compared-to-placebo-in-adults-without-hiv-100571775","NCT06724640","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV","A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled, Randomized, Single Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered Long-acting Formulations of VH4011499 in Adults Without HIV","Inclusion Criteria:\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy.\n* Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast\u002Fchest feeding or planning to breast\u002Fchest feed during the study and one of the following applies:\n\n  * Is a Participant of Nonchildbearing potential (PONCBP)\n  * Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n* Abnormal blood pressure.\n* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Breast cancer within the past 10 years.\n* Current or chronic history of liver disease, or known hepatic or biliary abnormalities.\n* History of clinically relevant hepatitis within last 6 months.\n* Patients with chronic hepatitis B infection.\n* History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.\n* The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.\n* Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded.\n* History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition.\n* Any preexisting physical or mental condition which may interfere with the participant's ability to comply with the dosing schedule and\u002For protocol evaluations or which may compromise the safety of the participant.\n* Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing\n* Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.\n* Current enrollment or recent past participation in another investigational study.\n* Positive HIV antibody\u002Fantigen test.\n* ALT more than or equal to (\\>=)1.5x upper limit of normal (ULN), Total bilirubin \\>=1.5x ULN (isolated total bilirubin more than (\\>)1.5xULN), and\u002For estimated creatinine clearance (eGFR) of less than (\\\u003C)60 millilitre per minute (mL\u002Fmin)\u002F1.73 square meter (m\\^2).\n* Regular use of tobacco or nicotine-containing products, regular alcohol consumption and\u002For use of known drugs of abuse.\n* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \\>450 msec.\n* Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and\u002For sinus pauses (\\>3 seconds).\n* The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.",{"count":303,"type":22},168,[25],"The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.",[28],[232,308,31,32,33,34,286,309,310],"VH4011499","Single ascending dose","Multiple ascending dose","2025-10-27",{"date":313,"type":42},"2025-10-29",{"date":315,"type":42},"2024-12-16",{"date":317,"type":22},"2028-08-16",{"name":48,"class":49},2,{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":331,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":335,"locationsCount":4},"100380396","fostemsavir-compassionate-use-named-patient-program-for-the-treatment-of-human-immunodeficiency-virus-1-hiv-1-100380396","NCT04233047","Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)","Inclusion Criteria:\n\n1. Patient has given consent for treatment\n2. Patient is male or non-pregnant female, age 18 years and older. NOTE: there may be allowance for a lower minimum age if dictated by local regulatory and\u002For legal requirements.\n3. Patient has chronic HIV-1 infection and is heavily treatment experienced\n4. Patient is experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c\u002FmL) on a current antiretroviral therapy (ART) regimen and:\n\n   1. is unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and\u002For intolerance and\u002For contraindication AND\n   2. has no more than 2 fully active ART agents (0, 1, or 2 ART agents) which can be paired with fostemsavir as part of a viable combination ART regimen\n5. Patient meets the following reproductive status criteria:\n\n   1. Women must not be breastfeeding\n   2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of fostemsavir and must agree to periodic pregnancy testing (as per local standard of care) for the duration of treatment with fostemsavir.\n   3. WOCBP must agree to use at least 1 method of effective contraception for the duration of treatment with fostemsavir and 60 hours after fostemsavir drug exposure. Males must inform their female partners who are WOCBP of the contraceptive requirements of the NPP to which they too are expected to adhere.\n   4. Males who are sexually active with WOCBP must use condoms for the duration of treatment with fostemsavir and 60 hours after last dose. In addition, males must be willing to refrain from sperm donation during this time.\n   5. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but must comply with the pregnancy testing schedule as outlined in inclusion criterion 5b.\n\nPhysicians shall counsel WOCBP and males who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. At a minimum, contraceptive counselling should be provided at the time of consent.\n\nExclusion Criteria:\n\nPatients will not be eligible for fostemsavir compassionate use if any of the following criteria apply:\n\n1. Patient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.\n2. Patient is taking one or more prohibited medications including:\n\n   1. strong CYP3A inducers including, but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John's wort (Hypericum perforatum, herbal supplement),\n   2. elbasvir\u002Fgrazoprevir (hepatitis C direct acting antiviral)\n3. Patient has a prior history of poor adherence with multiple failed attempts of oral ART","EXPANDED_ACCESS","Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure and are unable to comprise a suppressive regimen with currently available antiretrovirals.\n\nDirect inquires to the ViiV Compassionate Use Portal via https:\u002F\u002Fviiv-cu-portal.idea-point.com\u002F",[28],[330],"Human Immunodeficiency Virus 1 (HIV-1)","AVAILABLE","2025-05-12",{"date":334,"type":42},"2025-05-13",{"name":48,"class":49},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":343,"maxAge":106,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100491094","phase-1-pharmacokinetics-safety-tolerability-of-dolutegravirrilpivirine-in-pediatrics-100491094","NCT05674656","Pharmacokinetics, Safety, Tolerability of Dolutegravir\u002FRilpivirine in Pediatrics","Phase 1\u002F2 Study of Switching to Fixed Dose Combination Dolutegravir\u002FRilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1","Inclusion Criteria:\n\n* Human immuno virus Type-1 (HIV-1) infected child 6 years to less than 12 years of age at the time of signing the informed consent form .\n* Body weight greater than or equal to 25 kilogram (kg) at entry.\n* Confirmed HIV-1-infection\n* Participant has taken the same Antiretroviral therapy (ART) regimen in the 6 months (180 days) prior to Screening, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records.\n* Has a plasma HIV-1 Ribonucleic Acid (RNA) result less than 50 copies\u002FmL at Screening\n* Has at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 6-12 months (180-365 days) prior to Screening OR Has at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected less than 6 months (within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 12-18 months (365-545 days) prior to Screening\n* For participants of reproductive potential (defined as having reached menarche), not pregnant based on testing performed at Screening (i.e., from a specimen collected within 30 days prior to entry) and at Baseline\u002FDay 1.\n* For participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy, willing to use two methods of contraception while receiving study drug and for approximately one month after permanently discontinuing study drug, based on participant\u002Fparent\u002Fguardian report at entry.\n* For participants of reproductive potential, not breastfeeding based on participant\u002Fparent\u002F guardian report at Baseline\u002FDay 1.\n\nExclusion Criteria:\n\n* Documented resistance (ever) to Non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase inhibitors\n* Documented HIV-1 RNA result greater than or equal to the lower limit of detection of the assay based on a specimen collected in the 12 months (365 days) prior to Screening\n* Any change (ever) of any Antiretroviral (ARV) agent due to virologic failure, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* Has a history (ever) of allergy to DTG, RPV, or any other component of JULUCA as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records.\n* Has a history (ever) of congestive heart failure, symptomatic arrhythmia, or any clinically significant cardiac disease as determined by the site investigator based on participant\u002F parent\u002Fguardian report and available medical records\n* Has a history (ever) of unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* Has any of the following as determined by the site investigator based on participant\u002F parent\u002Fguardian report and available medical records: Current clinical evidence of pancreatitis; Currently active AIDS-defining (WHO Clinical Stage 4) opportunistic infection; Currently active TB and\u002For current rifamycin-containing TB treatment.\n* Has an anticipated need for any HCV therapy during the first 24 weeks of study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug: drug interactions with study treatment throughout the entire study period.\n* Receipt of the following as determined by the site investigator based on participant\u002F parent\u002Fguardian report and available medical records: Any investigational agent within 90 days prior to entry; Any prohibited medication within 30 days prior to entry; Any medication with a known risk of Torsades de Pointes within seven days prior to entry\n* Receipt (ever) of an ART regimen that included both DTG and RPV, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* Any ≥ grade 3 result for the following based on grading per the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Haemoglobin (\\\u003C8.5 gram per deciliter \\[g\u002FdL\\] or \\\u003C5.25 millimoles per liter \\[mmol\u002FL\\]); Absolute neutrophil count (\\\u003C600 cells\u002Fmm\\^3 or \\\u003C0.600 x 109 cells\u002FL); Platelet count (\\\u003C50,000cells\u002Fmm\\^3 or \\\u003C50.00 x 109 cells\u002FL); Estimated glomerular filtration rate (eGFR: \\\u003C60ml\u002Fmin\u002F1.73m\\^2); ALT (≥5.0 x Upper limit of Normal \\[ULN\\]); Aspartate Aminotransferase (AST) (≥5.0 x ULN)\n* Has the following combination of laboratory test results at screening: Alanine transaminase \\[ALT\\] greater than or equal to 3 x ULN and total bilirubin greater than or equal to 1.5 x ULN and direct bilirubin greater than 35% of total bilirubin\n* Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening.\n* QTc \\>450 milliseconds (msec) at Screening\n* Severe acute malnutrition (Body Mass Index \\[BMI\\] for age \\\u003C-3 or nutritional oedema)\n* Has any documented or suspected clinically significant medical or psychiatric condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.\n* The child is a ward of State or government.","6 Years",{"count":345,"type":22},20,[25,165],"The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA \\[Ribonucleic Acid\\] \\\u003C 50 \\[cells per milliliter\\] c\u002FmL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).",[28],[350,115,351],"Dolutegravir","JULUCA","2024-09-13",{"date":354,"type":42},"2024-09-19",{"date":356,"type":42},"2023-07-06",{"date":358,"type":22},"2028-05-03",{"name":48,"class":49},8,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":331,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":377,"locationsCount":4},"100321280","gsk1265744-cabotegravir-cab-for-named-patientcompassionate-use-in-hiv-100321280","NCT03462810","GSK1265744 (Cabotegravir, CAB) for Named Patient\u002FCompassionate Use in HIV","Inclusion Criteria:\n\n* HIV-infected patients will be eligible for treatment if ALL the following apply:\n\n  * Male or female patients aged ≥ 18 yrs\n\nNOTE: all female patients of reproductive potential should use every precaution to prevent pregnancy including either complete abstinence from intercourse from 2 weeks prior to administration of CAB, throughout receipt of CAB and for at least 52 weeks after discontinuation of CAB LA; or use of one of the following methods of highly reliable contraception:\n\n1. Contraceptive subdermal implant\n2. Intrauterine device or intrauterine system\n3. Combined estrogen and progestogen oral contraceptive\n4. Injectable progestogen\n5. Contraceptive vaginal ring\n6. Percutaneous contraceptive patches\n7. Male partner sterilisation with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's: review of subject's medical records, medical examination and\u002For semen analysis, or medical history interview provided by her or her partner.\n\nThese allowed methods of contraception are only effective when used consistently\u002Fcorrectly and in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.\n\n* Inability to construct a viable antiviral treatment regimen with commercially available medications;\n* Demonstrated need for a long acting, injectable antiretroviral including, but not limited to malabsorption or inability to achieve adequate drug levels via oral route. NOTE: Poor\u002Fincomplete adherence to oral meds is not a sufficient rationale for inclusion.\n* The patient\u002Flegal guardian or representative has given informed consent to treatment prior to administering CAB (in a manner consistent with all national requirements). The patient\u002Flegal guardian or representative has also given informed consent for the transmission of a copy of the anonymized adverse and serious adverse event (SAE) and pregnancy reports (in compliance with local regulatory authority requirements) to GSK and ViiV where allowable by local regulations, and to the country regulatory authority as required.\n\nExclusion Criteria:\n\n* Patients will not be eligible for treatment if ANY of the following apply:\n\n  * Patient has estimated creatinine clearance \\\u003C50 mL\u002Fmin via Cockcroft-Gault method;\n  * Females who are pregnant or women who are breastfeeding, or plan to become pregnant or breastfeed during treatment.\n  * Patients who have had known or suspected allergic reaction or hypersensitivity reactions to integrase inhibitors;\n  * Alanine aminotransferase (ALT) \\>5 times the upper limit of normal (ULN)\n  * ALT ≥ 3 times ULN and bilirubin ≥ 1.5 times ULN (with \\> 35% direct bilirubin)\n  * Evidence for moderate to severe hepatic impairment, grade 3-4 liver fibrosis, or cirrhosis\n  * Patients who are eligible for actively enrolling clinical trials involving CAB.\n  * Significant coagulopathy precluding chronic IM dosing\n\nNOTE: Patients should not be treated via the named patient\u002Fcompassionate use program if they are eligible and\u002For able to participate in any of the Phase III clinical trials of CAB and the patient is suitable for participation in such clinical trials. In that instance (assuming consent is obtained) the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection. In accordance with national requirements patients should not be treated in the named patient\u002Fcompassionate use program if they have responded to previous treatment with CAB in another clinical trial without review and prior approval by the VSLC.","The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and\u002For limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https:\u002F\u002Fus.viivhealthcare.com\u002Fmedia\u002F124424\u002Fviivs-external-policy-on-cup\\_final-version\\_23feb2017.pdf.",[369],"Infection, Human Immunodeficiency Virus",[371,372,373,116],"cabotegravir, CAB","GSK1265744","Individual Patient Compassionate Use","2021-05-19",{"date":376,"type":42},"2021-05-21",{"name":48,"class":49},""]