Clinical trials: HIV Risk
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus, HIV Infections
Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates.
- Trial name
- NCT03310515
- Testing
- Risk reduction counseling, Social harm interview, Computer-Assisted Self Interviewing technique
- Where
- 9 sites in China
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
AIDS, HIV Infections
Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become…
- Trial name
- NCT00095576
- Testing
- Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
- Trial name
- NCT06741397
- Testing
- CAB LA, New formulation of CAB LA
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Health Risk Behaviors
Sexually Active Adolescent Focused Education
SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and…
- Trial name
- SAAFE (NCT03646032)
- Testing
- SAAFE, Control
- Where
- 2 sites in United States
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
HIV Infections, HIV Seronegativity
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who are at risk from becoming infected with HIV.
- Trial name
- NCT00002441
- Testing
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- Where
- 67 sites in United States, Canada and 2 more
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- VaxGen
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
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) Infections
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for…
- Trial name
- NCT05130086
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
Each year up to 22 million persons in the US are tested for HIV. Currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject.
- Trial name
- NCT00514605
- Testing
- Behavioral counseling, HIV-1 Antibody Test Kit
- Where
- 14 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
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-1 Infection
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection
- Trial name
- NCT04003103
- Testing
- Islatravir
- Where
- 9 sites in United States, Israel and 1 more
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Prevention of Infection With HIV-1
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers.
- Trial name
- TMB-108 (NCT01292174)
- Where
- 6 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- TaiMed Biologics 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