Clinical trials: HIV-1-infection, open to volunteers
HIV Infections
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department…
- Trial name
- Screen Smart (NCT06003192)
- Testing
- Universal Opt-out HIV Screening
- Where
- 4 sites in United States
- Volunteers
- 63,000 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Insomnia, HIV Infections
Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms
Insomnia is common among people living with HIV and is linked to fatigue and lower quality of life. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment, but access is limited in Indonesia.
- Trial name
- NCT07892534
- Testing
- Telenursing-based sleep coaching
- Where
- Indonesia
- Volunteers
- 50 people
- Sponsor
- Universitas Indonesia
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
HIV-1-infection, Alcohol Drinking
Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited…
- Trial name
- NCT06648629
- Testing
- Acceptance and Commitment Therapy (ACT), Brief Alcohol Intervention
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Syracuse University
HIV Infections
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Trial name
- NCT07818915
- Testing
- VH4367310
- Where
- 2 sites in United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy
Systematic, continuative collection of clinical and laboratory data on patients followed at lnfectious Diseases Unit of the IRCCS San Raffaele Hospital in Milan, receiving long-acting ART (Phase IV, single-center, prospective…
- Trial name
- SCohoLART (NCT05663580)
- Testing
- Cabotegravir 600mg/3mL, Rilpivirine 900mg/3mL
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Castagna Antonella
HIV-1-infection
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and…
- Trial name
- NCT06337032
- Testing
- F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet)
- Where
- 15 sites in Argentina, Panama and 4 more
- Volunteers
- 350 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Immunotherapy With Baricitinib and Sirolimus, Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment Interruption
Natural HIV controllers (HICs) and post-treatment controllers (PTCs) are rare examples of people living with HIV (PLWH) who achieve control of HIV replication without the need for antiretroviral therapy (ART).
- Trial name
- NCT07081763
- Testing
- Baricitinib 2 MG, Sirolimus 2 MG
- Volunteers
- 191 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
This study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of people with HIV, called non-progressors, has been able to control HIV…
- Trial name
- NCT00029445
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection.
- Trial name
- NCT00039689
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies…
- Trial name
- NCT00789009
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Substance Abuse, Intimate Partner Violence (IPV)
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a…
- Conditions
- Substance Abuse, Intimate Partner Violence (IPV), HIV Infections, Depression
- Trial name
- SER Familia (NCT06627764)
- Testing
- SER Familia
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Prevention, HIV Infection Primary
Intervention to Enhance PrEP Persistence
The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care.
- Trial name
- NCT06872307
- Testing
- RAMP-It-Up Initiation, Adherence, and Retention Intervention
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV -1 Infection
Safety Study of MucoCept-CVN
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug.
- Trial name
- NCT07181486
- Testing
- Live Biotherapeutic Product L. jensenii 1153-1666
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Craig Cohen, MD, MPH
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
Acute HIV Infection
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: Administration of…
- Trial name
- NCT05719441
- Testing
- VRC07-523LS, PGT121.414.LS, ART
- Where
- 12 sites in United States, Brazil and 1 more
- Volunteers
- 48 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Contraception
Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time.
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction, PrEP
- Trial name
- PHARAOH (NCT07516548)
- Testing
- Long-acting injectable cabotegravir (CAB-LA), No PrEP
- Where
- Botswana
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
HIV Infections, Contraception
DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics.
- Conditions
- HIV Infections, Contraception, PrEP
- Trial name
- DYNAMIC PrEP (NCT07597824)
- Testing
- Observational cohort (PrEP use in real-world settings)
- Where
- Botswana
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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