Clinical trials: Human Immunodeficiency Virus Type 1
HIV-1 Infection
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and ultimately immune deficiency.
- Trial name
- IMID (NCT01704781)
- Testing
- Lenalidomide, Vacc-4X, rhuGM-CSF
- Where
- 4 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Bionor Immuno AS
HIV Infections
Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on…
- Trial name
- NCT00389207
- Testing
- nevirapine bid, nevirapine qd, atazanavir
- Where
- 68 sites in Argentina, Germany and 8 more
- Volunteers
- 576 people
- Sponsor
- Boehringer Ingelheim
HIV Prevention
OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults
This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated…
- Trial name
- NCT04791007
- Testing
- OB-002
- Where
- Poland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Orion Biotechnology Polska Sp. z o.o.
HIV Infections
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.
- Trial name
- NCT00002359
- Testing
- HIV-1 Immunogen
- Where
- 54 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- The Immune Response Corporation
Human Immunodeficiency Virus 1
A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination…
- Trial name
- MONARCH (NCT01391013)
- Testing
- Darunavir(DRV), Ritonavir, 2 nucleoside reverse transcriptase inhibitors (NRTIs)
- Volunteers
- 30 people
- Sponsor
- Janssen-Cilag S.p.A.
HIV-1-infection
Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)
The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.
- Trial name
- NCT05030025
- Testing
- abacavir, dolutegravir and lamivudine dispersible tablets, Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine
- Where
- Canada
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Healthy
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination
The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose combination (FDC) with darunavir (DRV) and…
- Trial name
- NCT02475135
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC, Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC, Darunavir
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC
HIV Infections
An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects
To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1 infected pediatric subjects and, if necessary, to…
- Trial name
- NCT00642291
- Testing
- Emtricitabine
- Where
- 2 sites in Romania
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an…
- Trial name
- AMICI (NCT00488059)
- Testing
- enfuvirtide [Fuzeon], Optimized background ARV, Integrase inhibitor
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
HIV I Infection
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
This is a Phase 1a, first in human study in which healthy adult participants who are considered to be at low-risk for HIV infection and are seropositive for cytomegalovirus (CMV) will receive two doses of VIR-1111 or placebo.
- Trial name
- NCT04725877
- Testing
- VIR-1111
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)
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
- NCT02831673
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 90 sites in United States, Argentina and 16 more
- Volunteers
- 719 people
- Sponsor
- ViiV Healthcare
HIV Infections
Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.
- Trial name
- NCT00005002
- Testing
- Lamivudine/Zidovudine, HIV-1 Immunogen, Nelfinavir mesylate
- Where
- United States
- Volunteers
- 688 people
- Sponsor
- Agouron Pharmaceuticals
Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US).
- Trial name
- NCT06368453
- Testing
- INSTI® HIV Self-Test
- Where
- United States
- Volunteers
- 1,728 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine…
- Trial name
- NCT02607930
- Testing
- ABC/DTG/3TC, B/F/TAF
- Where
- 121 sites in United States, Belgium and 8 more
- Volunteers
- 631 people
- Sponsor
- Gilead Sciences
HIV Infections
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or…
- Trial name
- NCT00120393
- Testing
- atazanavir/ritonavir +2 NRTIs (immediate Switch Group), LPV/r +2 NRTIs (Delayed/optional Switch Group)
- Where
- 14 sites in United States, Canada
- Volunteers
- 192 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants.
- Trial name
- NCT03639311
- Testing
- CAB LA, RPV LA, RPV
- Where
- 30 sites in United States, Canada
- Volunteers
- 97 people
- Sponsor
- ViiV Healthcare
HIV Infections
An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment
Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.
- Trial name
- NCT00675844
- Testing
- Elvucitabine
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV Infections
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1)…
- Trial name
- NCT00105079
- Testing
- saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 44 sites in United States, Canada and 3 more
- Volunteers
- 337 people
- Sponsor
- Hoffmann-La Roche
HIV-1 Infection in Adults
Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected Adults
The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by…
- Trial name
- NCT01668043
- Testing
- Antibody UB-421
- Where
- 2 sites in Taiwan
- Volunteers
- 29 people
- Sponsor
- United Biomedical
HIV Infections
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
- Trial name
- NCT00038220
- Testing
- Lopinavir/ritonavir, Efavirenz, Lamivudine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Abbott