Clinical trials: Human Immunodeficiency Virus Exposure
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin.
- Trial name
- NCT07600775
- Testing
- MK-8527, Rifampin
- Volunteers
- 14 people
- Sponsor
- Merck Sharp & Dohme LLC
Pre-exposure Prophylaxis for Prevention of HIV Infection
A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
This is a prospective, 3-year observational study to describe drug utilization in uninfected individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP)…
- Trial name
- NCT01865799
- Where
- United States
- Volunteers
- 64,186 people
- Sponsor
- Gilead Sciences
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
HIV Infections
Drug Exposure Registry for GSK2248761, an Investigational NNRTI
The World Health Organization has estimated that as many as 10% of the population worldwide may at some point experience at least one seizure. The percentage with active epilepsy is from 0.4% to 1%.
- Trial name
- NCT01458132
- Volunteers
- 19 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
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 as well as or…
- Trial name
- NCT07044297
- Testing
- MK-8527, FTC/TDF
- Where
- 81 sites in United States, Argentina and 14 more
- Volunteers
- 4,390 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pre-Exposure Prophylaxis of HIV Infection
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in…
- Trial name
- PURPOSE 3 (NCT06101329)
- Testing
- Lenacapavir Tablet, Lenacapavir Injection, Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
- Where
- 11 sites in United States
- Volunteers
- 253 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV
Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)
This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure…
- Trial name
- NCT01906255
- Where
- United States
- Volunteers
- 10,577 people
- Sponsor
- Gilead Sciences
Hiv
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages.
- Trial name
- NCT04233931
- Testing
- PrEP medication adherence mobile app
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
HIV Infections
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)
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…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus
To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for health care workers at risk for HIV infection from exposure to HIV-contaminated blood or blood components.
- Trial name
- NCT00002287
- Testing
- Zidovudine
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Glaxo Wellcome
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
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
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- Prevention
To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)
A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
- Trial name
- NCT02847286
- Testing
- Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole, Clotrimazole
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Infection, Human Immunodeficiency Virus
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children.
- Trial name
- NCT02634073
- Testing
- Lamivudine, Sorbitol
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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.
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or…
- Trial name
- NCT06783192
- Testing
- MK-8527, LNG/EE
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Fracture, Infection, Human Immunodeficiency Virus
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status
This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection.
- Trial name
- NCT01077557
- Testing
- No Antiretroviral (ARV) Drug Exposure, Any Antiretroviral (ARV) Drug Exposure
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
HIV Infections
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States.
- Trial name
- PROPEL (NCT07473778)
- Testing
- Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF)
- Where
- 44 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Gilead Sciences