[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infection-human-immunodeficiency-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infection-human-immunodeficiency-virus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100571365","phase-1-phase-ibiia-clinical-study-of-acc017-tablets-100571365",false,"NCT06719310","Phase Ib\u002FIIa Clinical Study of ACC017 Tablets","A Phase Ib\u002FIIa, Randomized, Double Blinded, Perallel, Dosing Ranging, Placebo Controled and Proof of Concept Clinical Trial to Evaluate the Safety, Tolerability, PK and Antiviral Effect of ACC017 Tablet as Monotherapy\u002FCombination With NRTI in Treatment naïve HIV-infected Adults","Inclusion Criteria:\n\n1. Willing to sign the informed consent and agree to comply to the study procedures and requests\n2. Age range between 18 and 65 years old at the time of signing informed consent, regardless of gender\n3. Body weight ≥40 kg, and BMI range between 18.5\\~29.9 kg\u002Fm2 (including the borderline) at screening\n4. Documented HIIV-1 infection before screening, and never receive any antiHIV-1 drugs or vaccines after the diagnosis of HIV-1 infection\n5. Agree not to use any antiviral drugs other than those allowed by protocol during study period.\n6. Plasma HIV RNA≥5000 copies\u002FmL at screening;\n7. CD4+ T-lymphocyte count of \\>200 cells\u002FμL\n\nExclusion Criteria:\n\n1. Diagnosis of acute HIV infection at screening or unstable AIDS related disease within 4 weeks prior to screening.\n2. Had PrEP and\u002For PEP treatment within 1 month prior to screening.\n3. Had uncontrolled severe disease judged by investigator, such as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg, NYHA class III or IV or fasting glucose ≥7.0 mmol\u002FL.\n4. History of serious allergy to drugs (such as aspirin or cephalosporin antibiotics) or their ingredients' or food (a fast, life-threatening systemic allergic reaction), or allergic disease requiring drug control (such as asthma, urticaria, atopic dermatitis \\[eczema\\].).\n5. Any major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy) or any surgery affecting drug absorption, distribution, metabolism and excretion within 6 months before screening; or possible elective surgery during the trial as judged by the investigator.\n6. History of cancer(except cervical carcinoma in situ, or cutaneous basal cell carcinoma, squamous cell carcinoma, and\u002For carcinoma in situ \\[Bowen's disease\\] that received radical surgery or treatment) within 5 years prior to screening.\n7. Hb \\\u003C90 g\u002FL, or WBC count \\\u003C1.5×109\u002FL, or ANC count \\\u003C0.6×109\u002FL, or platelet count \\\u003C50×109\u002FL at screening.\n8. ALT and\u002For AST \\> 2.5 times upper limit of normal (ULN), or TBIL \\> 1.5 × ULN, or DBIL \\> ULN, or ALB \\\u003C30 g\u002FL at screening.\n9. SCr \\> 1.3 ×ULN, or Ccr \\\u003C60 mL\u002Fmin (Cockcroft-Gault formula) at screening,\n10. Blood amylase or lipase \\>1.5 ×ULN\n11. Subjects with a positive for HBsAg or anti-HCV, or those with anti-Tp positive who need to be treated required by investigator or their treatment period \\\u003C7 days at screening.\n12. Average smoked cigarettes more than 5 a day within 3 months prior to screening or unwilling to stop using any tobacco products during hospitalization.\n13. Drinking more than 14 units per week within 3 months prior to screening ( 1 unit of alcohol is equivalent to 5% beer, 45 mL of 40% alcohol, 150mL of 12% alcohol), or a positive alcohol breath test at a screening or baseline visit, or unwilling to stop drink any alcohol-containing product during hospitalization.\n14. Excessive consumption of tea, coffee or caffeine ( more than 8 cups per day on average, 1 cup of 250 mL) or unwilling to stop drinking tea, coffee, or caffeine during hospitalization.\n15. Having taken pitaya, mango, grapefruit, star fruit or any preparations made from them, or food\u002Fdrinking containing xanthine, caffeine or alcohol (e.g.chocolate, tea, coffee, cola and cocoa) or others that will affect the absorption, distribution, metabolism, excretion of drugs, within 48 hours prior to the first dose of experimental drugs, or unwilling to stop taking them during hospitalization.\n16. Use of any potent or moderate CYP3A inhibitors (e.g. clarithromycin, thalimycin, ketocomazole, ketoconazole, itraconazole, and CYP3A4) or potent CYP3A4 inducers (e.g. rifampin, efavirenz,carbamazepine, phenobarbitone, phenytoin) within 14 days prior to the first dose of experimental drugs or within 5 half-lives(whichever is longer).\n17. Use of any potent or moderate UGT1A inhibitors (e.g. silybin. Ritonavir) or potent UGT1A1 inducers (e.g. rifampin, carbamazepine) within 14 days prior to the first dose of experimental drugs or within 5 half-lives (whichever is longer).\n18. Use of any prescription drug, nonprescription drug, Chinese traditional herbs within 14 days prior to the first dose of experimental drugs or within 5 half-lives (whichever is longer).\n19. History of drug dependence (social, psychological and physical impairment due to excessive, impropriate or addictive use of substances for any non-medical reason) within 5 years prior to screening, or positive urine drug screen at screening or baseline.\n20. Intolerance to venipuncture, or have a history of halo acupuncture or blood sickness, or have donated blood including component blood or have had substantial blood loss (more than 400 mL) or have received a blood transfusion within 3 months prior to screening, or plan to donate blood during study.\n21. Have special dietary requirements at screening, or refuse to accept a standard diet.\n22. Have participated in or are participating in another drug or medical device clinical study within 3 months prior to screening.\n23. Women who are pregnant or breastfeeding or who have a positive blood pregnancy test at screening.\n24. Have a birth plan (including conception, eggs or sperm donation) within 1 month before signing informed consent form until 3 months after last dose of experimental drugs or refuse to use effective any contraceptive methods.\n25. Other conditions exist that, in the judgement of the investigator, make participation in this study unsuitable.","ALL","18 Years","65 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib\u002FIIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of ACC017 monotherapy and combined with FTC\u002FTAF by sequency versus placebo in treatment-naïve HIV-1 infected adults. This study includes two stages, stage one is a single dose escalation, and all subjects will be co-administrated with FTC\u002FTAF at 200 mg\u002F25 mg on stage two. The study consists of a screening visit, baseline period, monotherapy period, and combination therapy period. Total 36 subjects will be randomized in a 5:1 ratio to receive one of three doses of ACC017 or placebo lasting for 10 days for monotherapy followed by 18 days for combination therapy.",[28],"Infection, Human Immunodeficiency Virus","RECRUITING","2024-12-02",{"date":32,"type":33},"2024-12-05","ACTUAL",{"date":35,"type":33},"2024-08-28",{"date":37,"type":21},"2025-11",{"name":39,"class":40},"Jiangsu Aidea Pharmaceutical Group Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":49,"conditions":50,"keywords":51,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":60,"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.","EXPANDED_ACCESS","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.",[28],[52,53,54,55],"cabotegravir, CAB","GSK1265744","Individual Patient Compassionate Use","HIV","AVAILABLE","2021-05-19",{"date":59,"type":33},"2021-05-21",{"name":61,"class":40},"ViiV Healthcare"]