Clinical trials: HIV1 Infection
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
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
HIV, Human Immunodeficiency Virus
An Extension of Protocol PRO 140_CD01 Study
This is an extension of Protocol PRO 140_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody)…
- Trial name
- NCT02355184
- Testing
- PRO 140 350mg weekly subcutaneous (SC) injection.
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CytoDyn, Inc.
HIV Infections
Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection
The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve…
- Trial name
- NCT00959894
- Testing
- Etravirine (Intelence), Truvada
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infection, HIV Infections
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
This study was designed to test the hypothesis that treatment of HIV infected subjects with losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will: 1. reverse existing lymphoid tissue fibrosis, 2.
- Trial name
- NCT01852942
- Testing
- Losartan
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
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 Infection
Single DermaVir Immunization in HIV-1 Infected Patients on HAART
DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells.
- Trial name
- GIHU004 (NCT00712530)
- Testing
- DermaVir, HAART
- Where
- Hungary
- Volunteers
- 9 people
- Sponsor
- Genetic Immunity
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir…
- Trial name
- NCT02831764
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 722 people
- Sponsor
- ViiV Healthcare
HIV-1-infection, Methamphetamine-dependence
Effect of Methamphetamine on Residual Latent HIV Disease Study
The most commonly used illicit stimulant in HIV-infected individuals is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation.
- Trial name
- EMRLHD (NCT03825536)
- Testing
- Oral Methamphetamine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Francisco
HIV-1 Infection
Pharmacokinetic Interactions Between DMPA and LPV/r Among HIV-Infected Women
This study was done to look at the level of Depo-Provera, an injectable birth control, in the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir [LPV/r]).
- Trial name
- NCT01296152
- Testing
- depo-medroxyprogesterone acetate
- Where
- 14 sites in United States, Puerto Rico
- Volunteers
- 25 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Infections
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy…
- Trial name
- NCT01302847
- Testing
- DTG film-coated tablets, DTG granules for suspension, DTG dispersible tablets
- Where
- 33 sites in United States, Botswana and 6 more
- Volunteers
- 181 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.
- Trial name
- NCT04097925
- Testing
- Doravirine, Descovy
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
HIV-1 Infection
Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants (MK-8558-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8558 monotherapy in anti-retroviral-naïve human immunodeficiency virus type 1 (HIV-1) infected participants.
- Trial name
- NCT03859739
- Testing
- MK-8558
- Where
- 2 sites in Germany, Romania
- Volunteers
- 21 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
- Trial name
- NCT04177355
- Testing
- BG505 SOSIP.664 gp140, 3M-052-AF, CpG 1018
- Where
- 10 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients…
- Trial name
- NCT00561925
- Testing
- nevirapine IR, nevirapine XR
- Where
- 202 sites in United States, Argentina and 19 more
- Volunteers
- 1,068 people
- Sponsor
- Boehringer Ingelheim
HIV Infections, Health Volunteers
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and…
- Trial name
- NCT02990325
- Testing
- ABX464 150mg, ABX464 50mg
- Where
- Spain
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Abivax S.A.
HIV Infections
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants
The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
- Trial name
- VRC07-523LS (NCT03735849)
- Testing
- VRC07-523LS
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens.
- Trial name
- NCT03682848
- Testing
- DTG + 3TC FDC
- Where
- 8 sites in Kenya, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
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