Clinical trials: HIV1 Infection
HIV-1
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the…
- Trial name
- NCT03060629
- Testing
- Ad26.Mos4.HIV, Clade C gp140
- Where
- 23 sites in Malawi, Mozambique and 3 more
- Volunteers
- 2,636 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
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 Prevention, Human Immunodeficiency Virus (HIV)
Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults
Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection.
- Trial name
- NCT03783130
- Testing
- VRC-HIVRGP096-00-VP, Alum Adjuvant
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB…
- Trial name
- ATLAS-2M (NCT03299049)
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension
- Where
- 119 sites in United States, Argentina and 11 more
- Volunteers
- 1,049 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection
In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172.
- Conditions
- Infection, Human Immunodeficiency Virus, HIV Infections, Arthralgia
- Trial name
- NCT02075593
- Testing
- DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets
- Where
- 3 sites in Russia, Spain
- Volunteers
- 4 people
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and…
- Trial name
- NCT01818596
- Testing
- E/C/F/TAF
- Where
- 70 sites in United States, Australia and 7 more
- Volunteers
- 252 people
- Sponsor
- Gilead Sciences
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
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
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 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 VH4004280 in healthy adults.
- Trial name
- NCT05163522
- Testing
- VH4004280, Midazolam
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
The aim of this study was to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02422797
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 61 sites in United States, Argentina and 9 more
- Volunteers
- 518 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
This is a open controlled trial in which 48 HIV-1 patients successfully treated with EFV/FTC/TDF will be randomized to one of 4 groups in equal proportion between arms (1:1).
- Trial name
- NCT01529749
- Testing
- EFV/FTC/TDF + Losartan, EFV/FTC/TDF, FTC/TDF + MK-0518
- Where
- Spain
- Volunteers
- 48 people
- Sponsor
- Felipe Garcia
HIV-1-infection
B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV.
- Trial name
- NCT03532425
- Testing
- B/F/TAF, Atripla
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- University of Alberta
Human Immunodeficiency Virus - Type 1
A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients…
- Trial name
- ODIN (NCT00524368)
- Testing
- Darunavir (DRV), Ritonavir (rtv)
- Where
- 85 sites in United States, Argentina and 17 more
- Volunteers
- 590 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C Infection With HIV Co-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02457611
- Testing
- LDV/SOF
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Kenya HIV Self-Testing in PrEP Delivery
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
- Trial name
- NCT03593629
- Testing
- 6-month PrEP + blood-based HIV self-test, 6-month PrEP + oral fluid HIV self-test
- Where
- Kenya
- Volunteers
- 790 people, healthy volunteers welcome
- Sponsor
- University of Washington
Hepatitis C, HIV Infections
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV…
- Trial name
- NCT00983853
- Testing
- peginterferon alfa-2a, ribavirin (fixed dose), ribavirin (weight-based dose)
- Where
- 16 sites in United States, France and 2 more
- Volunteers
- 62 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
HIV-1 Infection
Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted…
- Trial name
- NCT00892437
- Testing
- COBI, RTV, ATV
- Where
- 31 sites in United States
- Volunteers
- 85 people
- Sponsor
- Gilead Sciences
Infection, Human Immunodeficiency Virus
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.
- Trial name
- NCT02415595
- Testing
- BMS-955176, EFV, TDF/FTC
- Where
- 64 sites in United States, Argentina and 10 more
- Volunteers
- 210 people
- Sponsor
- ViiV Healthcare
HIV Infections
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV…
- Trial name
- NCT02591420
- Testing
- VRC01, Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
- Where
- 5 sites in Kenya, Tanzania and 2 more
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)