[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación Huésped\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100638694","phase-4-dolutegravirlamivudine-in-treatment-nave-pregnant-women-100638694",false,"NCT07616739","Dolutegravir\u002FLamivudine in Treatment-Naïve Pregnant Women","Evaluating the Efficacy and Safety of Dolutegravir\u002FLamivudine (DTG\u002F3TC) in ART-Naïve Pregnant Women","PREDUAL","Inclusion Criteria:\n\nAll persons who are eligible must meet all of the following:\n\n1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies\u002FmL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA\u002FEIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed.\n2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and\u002For PEP in the last 6 months.\n3. Ability to sign the informed consent form.\n4. Plasma HIV-1 RNA ≥1000 copies\u002FmL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant.\n\n6\\. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and\u002For ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center.\n\n7\\. The participant intends to continue with the pregnancy.\n\nExclusion Criteria:\n\nAll eligible individuals must NOT meet any of the following criteria:\n\n1. Documented resistance to 3TC (presence of the M184V\u002FI mutation) or DTG (defined as the presence of G118R, Q148 H\u002FK\u002FR, or R263K).\n2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).\n3. Hemoglobin \\\u003C8 g\u002FdL.\n4. Fetal abnormalities detected on ultrasound\n5. Concomitant medications required with possible drug interactions specified in section 5.10.\n6. ALT \\>=5 times the ULN, or ALT \\>=3xULN and bilirubin \\>=1.5xULN (with \\>35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification\n7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl \\\u003C50 mL\u002Fmin, total bilirubin, ALT, or AST).\n8. Active opportunistic infection at screening: active severe opportunistic infections and\u002For severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry.\n9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures.\n10. Problematic drug and\u002For alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.\n11. Known allergy or sensitivity to any of the study medications or their formulations.\n12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications.\n13. Creatinine Clearance of \\\u003C30 mL\u002Fmin . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.","FEMALE","15 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Protocol Number: FH-94\n\nStudy Objetives:\n\nPrimary:\n\n* To evaluate the virological response to Dolutegravir\u002FLamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.\n\nSecondary:\n\n* To evaluate the incidence of maternal adverse events.\n* To evaluate perinatal outcomes at delivery.\n* To evaluate maximum virological suppression at delivery.\n* To evaluate the incidence of changes in body weight exceeding what is expected for gestation.\n* To evaluate the immune response based on changes in CD4, CD8, and CD4\u002FCD8 ratio values during pregnancy.\n* Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF\u002FXTC or DTG+TAF\u002FFTC.\n* To evaluate the incidence of HIV infection in children that breastfeed.\n* To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF\u002FXTC or DTG+TAF\u002FFTC.\n\nExploratory:\n\n* To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF\u002FXTC or DTG+TAF\u002FFTC treatment.\n* To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.",[27],"HIV-1-infection",[29,30],"antiretroviral naive triple therapy","Dolutegravir-Lamivudine dual-therapy","NOT_YET_RECRUITING","2026-05-27",{"date":34,"type":35},"2026-06-01","ACTUAL",{"date":37,"type":21},"2026-06-15",{"date":39,"type":21},"2028-09-15",{"name":41,"class":42},"Fundación Huésped","OTHER",10,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100620435","phase-4-efficacy-and-safety-of-doravirine-in-the-rapid-initiation-100620435","NCT07357584","Efficacy and Safety of Doravirine in the Rapid Initiation","Efficacy and Safety of Doravirine in the Rapid Initiation of Highly Active Antiretroviral Therapy (HAART) in HIV-1positive Patients Without Prior Treatment","RapiDO","Inclusion Criteria:\n\n1. Subject has to voluntarily signed and dated an informed consent form, approved by an institutional ethics committee.\n2. ≥18 years of age.\n3. Not previously exposed to ARV (naïve). Subject may have received oral PrEP and PEP within the last 6 months and injectable PrEP and PEP within the last year.\n4. Have a received an HIV diagnosis within 30 days prior to selection. Defined as: Having confirmed HIV-1 infection. HIV-1 positive result is considered if the HIV1 RNA in plasma is ≥ 1000 copies\u002FmL or two HIV antibody tests (using two different tests) are positive.\n\n   NOTE: Participants may be included without knowing their baseline viral load. If baseline viral load results are less than 1000 copies\u002FmL, the volunteer's participation will be suspended and they will be considered to have failed the screening test. A viral load brought by the subject may be considered if it was performed within the last 30 days prior to the SCR visit.\n5. CD4+ T-cell count: No limit.\n6. Subjects able to meet the protocol requirements.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to doravirine, tenofovir, or lamivudine.\n2. Severe hepatic impairment (Child-Pugh C).\n3. Active HCV infection requiring specific treatment during study participation at the time of eligibility assessment. If HCV is diagnosed during the study and the participant requires treatment, the decision on whether to continue in the study will be at the investigator's discretion.\n4. A woman may be eligible to enter and participate in the study if she is not pregnant (confirmed by a negative urine pregnancy test at the time of screening\u002Fbaseline). If the baseline visit is scheduled on a different day than the SCR, the urine pregnancy test will be repeated) or breastfeeding and if at least one of the following conditions applies:\n\n   1. Women without reproductive capacity, defined as premenopausal women with tubal ligation or hysterectomy, or documented bilateral oophorectomy; or as postmenopausal women with 12 months of spontaneous amenorrhea, and women ≥ 45 years of age without hormone replacement therapy.\n   2. Women with reproductive capacity who agree to adopt one of the contraceptive options in Appendix 2 for at least 30 days after the last dose of study medication and\u002For completion of the follow-up visit.\n\n   The chosen contraceptive method must be used consistently, according to the approved product label. All study participants must be advised on safer sex practices, including the use of effective barrier methods, and the choice of effective contraceptive method must be documented in the eCRF (Electronic Case Report Form).\n5. The subject's general health status, in the investigator's oIPnion, interferes with the requirements of the study.\n6. Has a diagnosis of an active opportunistic infection defining AIDS or a malignant neoplasm within 30 days prior to evaluation (except Kaposi's sarcoma with fewer than 10 skin lesions).\n7. Is participating or has participated in a clinical study in the last 6 months.\n8. Creatinine clearance (CrCl) ≤50 mL\u002Fmin according to the Cockcroft-Gault equation.\n9. Any verified Grade 4 abnormality (except liIPds: HDL, LDL, total cholesterol, triglycerides).\n10. History or presence of allergy to study drugs or their components, or to drugs in their class.\n11. Subjects taking any medication during the study, including over-the-counter medications and herbal preparations, without the approval of the study physician.\n12. Mutations resistant to doravirine, 3TC, or TDF, according to the list described below:\n\nDOR mutations (INNTI):\n\nDoravirine (INNTI) Primary: the presence of one or more ART-resistant mutations will be grounds for exclusion.\n\nMutations: V106A\u002FM, F227C\u002FV, L234I, Y188L, Y318F, M230I\u002FL. Secondary: the presence of one or more RAMs will be grounds for exclusion. Mutations: A98G, V108I, G190E, H221Y, P225H, F227L, P236L. Others: the presence of five or more RAMs will be grounds for exclusion. Mutations: V90I, L100I, K101E\u002FH\u002FP, K103N\u002FR\u002FS, V106I, I135T, Y181C\u002FI\u002FV, E138A\u002FG\u002FK\u002FQ\u002FR, V170F\u002FT, G190A\u002FQ\u002FS, Y188C\u002FH, F227I, V245E, K311R.\n\nNRTI (TDF) Relevant mutations: Presence of one or more RAM Mutations: K65R, insertion 69, K70R\u002FE, Q151M,\n\nNRTI (3TC) Relevant mutation Presence of IM184V","ALL","18 Years","90 Years",{"count":56,"type":21},100,[24],"Protocol title: \"Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment.\"",[27],[61,62,63,64],"Efficacy","Safety","Doravirine","Rapid initiation of highly active antiretroviral therapy","2026-01-20",{"date":67,"type":35},"2026-01-22",{"date":69,"type":21},"2026-07-13",{"date":71,"type":21},"2028-01-13",{"name":41,"class":42},""]