Clinical trials: HIV-1 Infections
HIV-1 Infection
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily…
- Trial name
- NCT04233216
- Testing
- ISL, DOR, DOR/ISL
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 35 people
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV.
- Trial name
- NCT00296504
- Testing
- fosamprenavir (GW433908), ritonavir
- Where
- 24 sites in United States, Brazil and 6 more
- Volunteers
- 753 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency…
- Trial name
- NCT04564547
- Testing
- Islatravir, Ulonivirine, BIC/FTC/TAF
- Where
- 23 sites in United States, France and 1 more
- Volunteers
- 161 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
Group-Based Intervention to Improve Mental Health and Adherence Among Youth Living With HIV in Low Resource Settings
IMPAACT 2016 was a multi-site, two-arm, individually randomized, controlled study to evaluate whether an Indigenous Leader Outreach Model (ILOM) of trauma-informed cognitive behavioral therapy (TI-CBT) delivered by Indigenous…
- Trial name
- NCT04024488
- Testing
- Youth TI-CBT Intervention Arm, Youth Discussion Control Arm, Caregiver TI-CBT Intervention Arm
- Where
- 8 sites in Botswana, Malawi and 2 more
- Volunteers
- 484 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infections
A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.
The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease…
- Trial name
- NCT00976950
- Testing
- Tipranavir, ritonavir
- Where
- 20 sites in Romania
- Volunteers
- 42 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus…
- Trial name
- RANIA (NCT02116660)
- Testing
- Raltegravir (MK-0518), Nevirapine, Lamivudine
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV/AIDS, HIV-1-infection
Simplifying Treatment and Monitoring for HIV (STREAM HIV)
This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in…
- Trial name
- NCT04341779
- Testing
- Point-of-care viral load testing and tenofovir adherence testing
- Where
- South Africa
- Volunteers
- 539 people
- Sponsor
- University of Washington
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
Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial.
- Trial name
- NCT04538040
- Testing
- Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Quest Clinical Research
Infection, Human Immunodeficiency Virus I
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96.
- Trial name
- SPRING-2 (NCT01227824)
- Testing
- GSK1349572 (dolutegravir), raltegravir, ABC/3TC
- Where
- 101 sites in United States, Australia and 7 more
- Volunteers
- 828 people
- Sponsor
- ViiV Healthcare
HIV-1-infection
An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study
This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC (subcutaneous) monotherapy to…
- Trial name
- NCT05271370
- Testing
- PRO 140 350, PRO 140 525, PRO 140 700
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- CytoDyn, Inc.
HIV Infections
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the…
- Trial name
- NCT00530920
- Testing
- tipranavir, ritonavir
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 85 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an…
- Trial name
- INDUMA (NCT00207142)
- Testing
- Atazanavir + 2 NRTIs, Atazanavir + Ritonavir + 2 NRTIs
- Where
- 27 sites in Estonia, France and 8 more
- Volunteers
- 252 people
- Sponsor
- Bristol-Myers Squibb
HIV-1 Infection
Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone…
- Trial name
- NCT02616783
- Testing
- E/C/F/TAF, TDF, FTC
- Where
- 35 sites in Belgium, France and 3 more
- Volunteers
- 167 people
- Sponsor
- Gilead Sciences
HIV Infections
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
- Trial name
- NCT01539226
- Testing
- Dapivirine Vaginal Ring, 25 mg
- Where
- 7 sites in South Africa, Uganda
- Volunteers
- 1,959 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infection
Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive…
- Trial name
- onceMRK (NCT02131233)
- Testing
- Reformulated Raltegravir, Raltegravir, TRUVADA™
- Volunteers
- 802 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
This is a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571…
- Trial name
- NCT05828095
- Testing
- INO-6160, 2 mg, Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of…
- Trial name
- NCT02616029
- Testing
- E/C/F/TAF
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 66 people
- Sponsor
- Gilead Sciences
HIV Infection, Infection, Human Immunodeficiency Virus
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or…
- Trial name
- NCT00363142
- Testing
- Half-boosted Fosamprenavir, Full Boosted Fosamprenavir
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 211 people
- Sponsor
- GlaxoSmithKline
HIV-1 Infection
Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
Adult participants (18-64 years old) with HIV-1 Infection on ART with a CD4 T cell count ≥ 350 cells/mm3 and viral suppression for ≥ 24 months will be enrolled on this study.
- Trial name
- NCT03803605
- Testing
- VRC07-523LS, Vorinostat (VOR)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of North Carolina, Chapel Hill