Clinical trials: HIV Prevention
HIV-I, Human Immunodeficiency Virus Type 1
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection.
- Conditions
- HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
- Trial name
- Impower-022 (NCT04644029)
- Testing
- Islatravir, FTC/TDF
- Where
- 24 sites in United States, South Africa and 1 more
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hiv
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men.
- Trial name
- NCT04633200
- Testing
- DOT mobile app
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
HIV Prevention
To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women
A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women
- Trial name
- NCT02862171
- Testing
- Dapivirine Vaginal Ring-004
- Where
- 6 sites in South Africa, Uganda
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type…
- Trial name
- NCT02315703
- Testing
- Ad26.Mos.HIV, MVA-Mosaic, gp140 DP Low-dose
- Where
- 12 sites in United States, Rwanda and 3 more
- Volunteers
- 393 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Human Immunodeficiency Virus (HIV)
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV…
- Trial name
- PEPDar (NCT01516970)
- Testing
- Darunavir/Ritonavir (DRV/r), Lopinavir in fixed combination with Ritonavir, Zidovudine
- Where
- 17 sites in Germany
- Volunteers
- 312 people
- Sponsor
- Janssen-Cilag G.m.b.H
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)
This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects.
- Trial name
- NCT02076178
- Testing
- 744 Tablet, 744 LA Injection
- Where
- 10 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Preexposure Prophylaxis
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who…
- Trial name
- Impower-024 (NCT04652700)
- Testing
- ISL, FTC/TDF, FTC/TAF
- Where
- 25 sites in United States, Brazil and 5 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV, HIV Pre-exposure Prophylaxis
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1)…
- Trial name
- NCT06045507
- Testing
- MK-8527
- Where
- 18 sites in United States, Israel and 1 more
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus (HIV) Prophylaxis
Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women
This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC)…
- Trial name
- NCT02431273
- Testing
- TDF IVR, TDF-FTC IVR, TDF-FTC-MVC IVR
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Auritec Pharmaceuticals
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in…
- Trial name
- PILLAR (NCT05374525)
- Testing
- APRETUDE, Cabotegravir OLI
- Where
- 17 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines
HIV Infection, Sexually Transmitted Infections
Technology-based Training Tool for PHAT Life
Youth under age 18 involved in the criminal justice system are disproportionately minorities \& affected by substance abuse, mental illness, \& HIV/STI.
- Conditions
- HIV Infection, Sexually Transmitted Infections, Implementation
- Trial name
- PhatLife-II (NCT05339412)
- Testing
- Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
HIV Infections
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
- Trial name
- ASPIRE (NCT01617096)
- Testing
- Dapivirine Vaginal Ring
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 2,629 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections, HSV-2 Genital Herpes
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013…
- Trial name
- NCT00740584
- Testing
- 3% SPL7013 Gel (VivaGel)
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Starpharma Pty Ltd
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences