Clinical trials: HIV-1 Infection, open to volunteers
HIV Infections
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
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.
- Trial name
- NCT07202546
- Testing
- VH4524184, Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets, Dolutegravir / Lamivudine (DTG/3TC)
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 186 people
- Sponsor
- ViiV Healthcare
HIV Infections
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in…
- Trial name
- NCT07682961
- Testing
- Lenacapavir, Lenacapavir Tablet, Teropavimab
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 590 people
- Sponsor
- Gilead Sciences
HIV Infections
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
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…
- Trial name
- NCT05674656
- Testing
- Dolutegravir/Rilpivirine FDC
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
A Phase Ⅱa Clinical Study of CL-197 Capsules
This study will evaluate the antiretroviral activity, safety and pharmacokinetics of single dose of CL-197 capsule in three dose groups administered to antiretroviral treatment-naïve adult participants with human immunodeficiency…
- Trial name
- NCT07308782
- Testing
- CL-197 capsules
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Henan Genuine Biotech Co., Ltd.
HIV-1-infection
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy…
- Trial name
- NCT07645287
- Testing
- GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet
- Where
- 57 sites in United States, Australia and 2 more
- Volunteers
- 175 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
The goal of this clinical trial is to assess the effectiveness and safety of switching to bictegravir/lenacapavir (BIC/LEN) fixed-dose combination (FDC) compared with continuing stable baseline regimens (SBR) in virologically…
- Trial name
- ARTISTRY-3 (NCT07908446)
- Testing
- BIC/LEN FDC, Lenacapavir, SBR
- Volunteers
- 400 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in…
- Trial name
- NCT07683000
- Testing
- Lenacapavir, Lenacapavir Tablet, Teropavimab
- Where
- 2 sites in United States
- Volunteers
- 590 people
- Sponsor
- Gilead Sciences
HIV-1-infection
A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir
To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption.
- Trial name
- NCT04985890
- Testing
- UB-421, UB-421+chidamide
- Volunteers
- 20 people
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd
HIV1 Infection, HIV 2 Infection
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples…
- Conditions
- HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07569913
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- Australia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection better than a…
- Trial name
- NCT07071623
- Testing
- MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF)
- Where
- 30 sites in Kenya, South Africa and 1 more
- Volunteers
- 4,580 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI).
- Trial name
- CINERGY (NCT07816250)
- Testing
- VH4011499, CAB, DTG/3TC
- Volunteers
- 200 people
- Sponsor
- ViiV Healthcare
HIV 1 Infection, HIV 2 Infection
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care…
- Conditions
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07563309
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- 3 sites in South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Infection, Human Immunodeficiency Virus
Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)
This study employs a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design.
- Trial name
- NCT07711223
- Testing
- ACC017+FTC/TAF, DTG+FTC/TAF
- Where
- China
- Volunteers
- 660 people
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
HIV-1 Infection
Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
- Trial name
- NCT07841990
- Testing
- B/F/TAF, GS-3242, Lenacapavir
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
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.
- Trial name
- CABNATE (NCT07275606)
- Testing
- Oral CAB, IM CAB LA
- Where
- South Africa
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1-infection
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and…
- Trial name
- NCT06749054
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR)
- Where
- 9 sites in United States, South Africa
- Volunteers
- 12 people
- Sponsor
- Gilead Sciences
HIV -1 Infection
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and…
- Trial name
- NCT07698600
- Testing
- BNT168
- Where
- 4 sites in United States, South Africa
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in…
- Trial name
- NCT07266831
- Testing
- ISL, ULO, BIC/FTC/TAF
- Where
- 56 sites in United States, Argentina and 7 more
- Volunteers
- 570 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101
Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).
- Trial name
- NCT05143307
- Testing
- EBT-101
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Excision BioTherapeutics
HIV-1, HIV Infection
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are…
- Trial name
- NCT07862569
- Testing
- DOR/ISL
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC