Clinical trials: At Risk for HIV
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 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
EBV-induced Lymphomas, EBV-associated Malignancies
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
- Conditions
- EBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
- Trial name
- NCT00002663
- Testing
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Atara Biotherapeutics
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
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19)
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19), Immunocompromised, Hospitalization
- Trial name
- EPIC-HOS (NCT05545319)
- Testing
- Nirmatrelvir, Ritonavir
- Where
- 11 sites in United States, Bulgaria
- Sponsor
- Pfizer
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
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
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
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
SARS-CoV-2 Infection
A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)
This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults…
- Trial name
- COVID-19 (NCT05112848)
- Testing
- NVX-CoV2373
- Where
- 7 sites in South Africa
- Volunteers
- 384 people
- Sponsor
- Novavax
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
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
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
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