Clinical trials: HIV1 Infection
HIV-1 Infections
Post-Licensure Safety Study of ISENTRESS™ (Raltegravir) in a United States Managed Care Network (MK-0518-268)
The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.
- Trial name
- NCT01078246
- Volunteers
- 7,124 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
- Trial name
- NCT00594646
- Testing
- TRUVADA + Raltegravir
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
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-1-infection, Sleep Deprivation
Poor Sleep and Inflammation in HIV-Infected Adults
People living with HIV (PLWH) often have poor sleep, which may put them at a higher risk for many chronic diseases, including cardiovascular disease.
- Conditions
- HIV-1-infection, Sleep Deprivation, Inflammation
- Trial name
- SASH (NCT03848325)
- Testing
- Sleep deprivation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pittsburgh
HIV, HIV Infections
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen.
- Conditions
- HIV, HIV Infections, Acquired Immunodeficiency Syndrome
- Trial name
- NCT01967940
- Testing
- TAF, E/C/F/TAF, Current failing ARV regimen
- Where
- 15 sites in United States, Dominican Republic and 3 more
- Volunteers
- 55 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study of Options for Second-Line Effective Combination Therapy (SELECT)
The study was conducted on people who were taking their first anti-HIV drug regimen (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV drug) but the drugs in this regimen were not doing a…
- Trial name
- SELECT (NCT01352715)
- Testing
- Lopinavir/ritonavir, Raltegravir, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 16 sites in Brazil, India and 7 more
- Volunteers
- 515 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV-1 Infections
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo…
- Trial name
- NCT00799058
- Testing
- dapivirine 4789, dapivirine gel 4759
- Where
- 5 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1 Infection
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination…
- Trial name
- NCT03405935
- Testing
- B/F/TAF
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 86 people
- Sponsor
- Gilead Sciences
HIV Infections
Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and…
- Trial name
- NCT03984812
- Testing
- GSK3732394
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1 Infection
A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure
The study was done to: test a strategy of using a resistance test to choose anti-HIV drugs see how well combinations of new anti-HIV drugs work to lower HIV infection see if taking new anti-HIV drugs together is safe and…
- Trial name
- MULTI-OCTAVE (NCT01641367)
- Testing
- Darunavir, Etravirine, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 19 sites in Brazil, Haiti and 8 more
- Volunteers
- 545 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV-1-infection on Healthy Volunteers
The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
This study will investigate changes in insulin resistance, lipid metabolism and endocrine profile in HIV-negative subjects exposed to dolutegravir (an antiretroviral drug used in HIV treatment) in order to investigate the role…
- Trial name
- DTG Clamp (NCT04771754)
- Testing
- Dolutegravir
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
HIV Infections
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
- Trial name
- SOLAR (NCT04542070)
- Testing
- Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets
- Where
- 117 sites in United States, Australia and 12 more
- Volunteers
- 687 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection, HIV Infections
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.
- Trial name
- PARC002 (NCT00833781)
- Testing
- mRNA-transfected autologous dendritic cells, autologous dendritic cells with no mRNA transfection
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Massachusetts General Hospital
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Human Immunodeficiency Virus (HIV)
Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439A) 100 mg +…
- Trial name
- DRIVE-AHEAD (NCT02403674)
- Testing
- Doravirine, Tenofovir, Lamivudine, ATRIPLA™
- Volunteers
- 734 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines.
- Trial name
- NCT02463227
- Testing
- VRC01
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140…
- Trial name
- NCT02859961
- Testing
- PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg)
- Where
- 12 sites in United States
- Volunteers
- 562 people
- Sponsor
- CytoDyn, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects.
- Trial name
- NCT01641809
- Testing
- GSK1265744 10 mg, GSK1265744 30 mg, GSK1265744 60 mg
- Where
- 48 sites in United States, Canada
- Volunteers
- 244 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption
This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART and its safety during a brief analytical interruption of…
- Trial name
- NCT02446847
- Testing
- 3BNC117, ART Interruption
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Rockefeller University
HIV Infections
Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults
Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV.
- Trial name
- NCT03945981
- Testing
- Dolutegravir + Lamivudine FDC
- Where
- 16 sites in United States
- Volunteers
- 131 people
- Sponsor
- ViiV Healthcare