Clinical trials: Anti-Retroviral Agents
HIV Coinfection
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
- Trial name
- NCT01327547
- Testing
- Maraviroc
- Where
- 48 sites in United States, Czechia and 7 more
- Volunteers
- 138 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of severe acne) on the immune system.
- Trial name
- NCT01969058
- Testing
- Isotretinoin
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 76 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV Disease
Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy
The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young…
- Trial name
- P1094 (NCT01338025)
- Testing
- HAART regimen, 3TC or FTC monotherapy
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 33 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Human Immunodeficiency Virus
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents.
- Trial name
- NCT00791700
- Testing
- Maraviroc
- Where
- 41 sites in United States, Brazil and 7 more
- Volunteers
- 103 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve…
- Trial name
- NCT04233879
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 95 sites in United States, Argentina and 11 more
- Volunteers
- 599 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV
A Two Year Study of the Clinical Efficacy of the Combination of Emtricitabine, Tenofovir, and Nevirapine
Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled.
- Trial name
- NCT00344461
- Testing
- Nevirapine, FTC, and Tenofovir
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Maryland, Baltimore
HIV-1 Infection
A Study of the Safety and Antiretroviral Activity of 3BNC117
This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART, and its safety during a brief analytical interruption of…
- Trial name
- NCT02588586
- Testing
- 3BNC117, Antiretroviral Treatment Interruption
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Rockefeller University
Infection, Human Immunodeficiency Virus
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of…
- Trial name
- SONNET (NCT01199731)
- Testing
- GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Etravirine
- Where
- 41 sites in United States, Belgium and 3 more
- Volunteers
- 30 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus Type 1
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
- Trial name
- NCT00110305
- Testing
- TMC278 25 mg, TMC278 75 mg, TMC278 150 mg
- Where
- 40 sites in United States, Argentina and 12 more
- Volunteers
- 368 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV-1 Infection
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults
The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen…
- Trial name
- NCT02605954
- Testing
- E/C/F/TAF, ABC/3TC, Third Antiretroviral Agent
- Where
- 49 sites in United States, France and 4 more
- Volunteers
- 275 people
- Sponsor
- Gilead Sciences
HIV Infections
R5 Integrase Study in HIV-1 Naive Patients
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients.
- Trial name
- NCT01204905
- Testing
- Raltegravir and Maraviroc in combination
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Maryland, Baltimore
HIV, AIDS
Kaiser Permanente HIV Cohort Study
Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events.
- Trial name
- NCT01339403
- Testing
- non-interventional trial
- Volunteers
- 282,368 people
- Sponsor
- ViiV Healthcare
HIV Infections, Drug Use
Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial
The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention…
- Trial name
- SNaPR01 (NCT03952520)
- Testing
- Standard Approach (SA), Tailored Approach (TA)
- Where
- Vietnam
- Volunteers
- 1,000 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV-associated Co-morbidities
Vitamin D Supplements for HIV-positive Patients on cART
The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the adverse medication consequences of HIV/AIDS, but little is known about either the health benefits of vitamin D supplements, or about the…
- Trial name
- NCT01295034
- Testing
- conventional vitamin D treatment, tiered/titrated vitamin D dosing
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Andrea Branch
HIV/AIDS, Cocaine Use
Project SMART Automated Pillbox Study
The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).
- Trial name
- SMART (NCT04418076)
- Testing
- Group A_No feedback, Group B_Automated feedback, Group C_Automated feedback + Clinician feedback
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Yale University
Human Immunodeficiency Virus
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART): 1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as…
- Trial name
- ARROW (NCT02028676)
- Testing
- Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI
- Where
- 4 sites in Uganda, Zimbabwe
- Volunteers
- 1,206 people
- Sponsor
- Medical Research Council
HIV Infection
Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected people who have never received anti-HIV therapy be treated with a triple drug regimen (commonly called combination antiretroviral…
- Trial name
- NCT00851799
- Testing
- Emtricitabine/tenofovir disoproxil fumarate, Ritonavir, Atazanavir
- Where
- 26 sites in United States
- Volunteers
- 334 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Infection, Human Immunodeficiency Virus
A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.
- Trial name
- NCT01499199
- Testing
- Dolutegravir
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- ViiV Healthcare
HIV/AIDS, Adherence
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).
- Trial name
- NCT01957865
- Testing
- Fixed SMS, real-time monitoring, Triggered SMS, real-time monitoring
- Where
- Uganda
- Volunteers
- 63 people
- Sponsor
- Massachusetts General Hospital
Acquired Immunodeficiency Syndrome, HIV Infections
Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus…
- Trial name
- NCT01497899
- Testing
- E/C/F/TDF, E/C/F/TAF
- Where
- 41 sites in United States, Puerto Rico
- Volunteers
- 279 people
- Sponsor
- Gilead Sciences