Clinical trials: HIV-1
HIV-1 Infection
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3)…
- Trial name
- M&M (NCT03844386)
- Testing
- MVA.tHIVconsv3, MVA.tHIVconsv4
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1
The purpose of this study was to assess the safety, tolerability, antiviral activity, and pharmacokinetics of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody VRC-HIVMAB075-00-AB (VRC07-523LS)…
- Trial name
- NCT03739996
- Testing
- Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Long-Acting Injectable Cabotegravir (CAB LA)
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 75 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response
The purpose of this study is to determine whether the addition of Pyridostigmine to Highly Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant patients in which viral load diminishes, but…
- Trial name
- NCT00518154
- Testing
- Pyridostigmine tablets
- Where
- 2 sites in Mexico
- Volunteers
- 7 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Human Immunodeficiency Virus 1
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in…
- Trial name
- NCT00919854
- Testing
- Darunavir, Ritonavir
- Where
- 8 sites in Argentina, Brazil and 3 more
- Volunteers
- 27 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV
DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects
Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that evolved from a prototype compound synthesized using structure-based design strategies.
- Trial name
- DRIVESHAFT (NCT01423812)
- Testing
- Twice-daily combination Darunavir and ritonavir, Once-daily combination Darunavir and ritonavir
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Ruth M. Rothstein CORE Center
HIV-1
HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and tissue-type plasminogen activator release in anti-retroviral (ART)-treated…
- Trial name
- NCT04956861
- Testing
- Individualized Targeted Sleep
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Colorado, Boulder
HIV-1 Infection, Neuropathic Pain
Pregabalin Trial In HIV Neuropathic Pain
This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
- Trial name
- NCT01145417
- Testing
- pregabalin (Lyrica)
- Where
- 29 sites in United States, Colombia and 5 more
- Volunteers
- 217 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
HIV Infections
Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid
This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral fluids.
- Trial name
- HIVOF (NCT00636220)
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Chembio Diagnostic Systems, Inc.
HIV Infections
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV.
- Trial name
- NCT00414518
- Testing
- Tenofovir disoproxil fumarate/Emtricitabine, Lopinavir/Ritonavir
- Where
- 3 sites in United States, Zimbabwe
- Volunteers
- 16 people
- Sponsor
- University of Colorado, Denver
Resilience, HIV-1-infection
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging With HIV
This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.
- Conditions
- Resilience, HIV-1-infection, Stress, Psychological
- Trial name
- RISE+ (NCT05314088)
- Testing
- RISE+, Stress Reduction Control
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of Alabama at Birmingham
HIV-1 Infection
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
The primary objectives of this study are: Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day…
- Trial name
- NCT03739866
- Testing
- Lenacapavir, B/F/TAF, TAF
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Gilead Sciences
HIV -1 Infection, HIV Infections
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
The purpose of this study is: 1. To assess the antiviral activity of PRO 140 2. To assess the safety and tolerability of PRO 140 3. To generate additional PK, PD and safety data of PRO 140
- Trial name
- NCT00642707
- Testing
- PRO 140 (humanized monoclonal antibody to CCR5)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- CytoDyn, Inc.
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults
The purpose of this study is to evaluate the safety and pharmacokinetics of PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal…
- Trial name
- NCT03408899
- Testing
- PC-1005 gel
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa
This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD.
- Trial name
- DISCO (NCT04066036)
- Testing
- This is an observational study only.
- Where
- 2 sites in South Africa, Uganda
- Volunteers
- 999 people
- Sponsor
- Massachusetts General Hospital
HIV
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/…
- Trial name
- NCT01620944
- Testing
- Atazanavir, Ritonavir, Lamivudine
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
HIV-1 Infection
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable suppressed viremia and no prior virologic…
- Trial name
- NCT01511809
- Testing
- Atazanavir/ritonavir monotherapy
- Where
- Italy
- Volunteers
- 117 people
- Sponsor
- IRCCS San Raffaele
HIV-1-infection
Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals
Doravirine is a new HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) that has demonstrated a good efficacy and safety profile in clinical trials.
- Trial name
- NCT04079452
- Testing
- Doravirine, Descovy
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
HIV-1-infection, Alcohol Drinking
Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
This study will examine whether moderate alcohol use in the context of HIV infection exacerbates inflammatory signaling in the immune system and brain.
- Trial name
- NCT04050735
- Testing
- Alcohol, ethyl, moderate dose
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV
Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME STUDY
The project presented here will be the first prospective, randomized evaluation of the effect of ART on the structure and function of the gut microbiome.
- Trial name
- NCT03029689
- Testing
- Raltegravir, Current ART
- Where
- Spain
- Volunteers
- 61 people
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia