Clinical trials: Antivirals/HIV
HIV Infections
Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection
The objective of the study is to compare two different doses of Peg-INF-α-2A (90 or 180 ug/wk) for their ability to maintain viral control when initiated 5 weeks before ART (antiretroviral therapy) interruption in HIV positive…
- Trial name
- NCT00594880
- Testing
- Pegylated Interferon-alpha 2a, 180 mcg/week sc, Pegylated Interferon-alpha 2a, 90 mcg/week sc
- Where
- 5 sites in United States
- Volunteers
- 23 people
- Sponsor
- The Wistar Institute
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic…
- Trial name
- NCT02472886
- Testing
- LDV/SOF, RBV
- Where
- 20 sites in Estonia, Russia
- Volunteers
- 153 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
- Trial name
- NCT00293267
- Testing
- raltegravir potassium
- Volunteers
- 352 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is increasing, leading to treatment failure.
- Trial name
- NCT01504841
- Testing
- Etravirine (ETR)
- Where
- 11 sites in United States, Brazil and 1 more
- Volunteers
- 26 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
- Trial name
- NCT01923311
- Testing
- EVG, Background regimen
- Where
- 11 sites in United States, Italy and 4 more
- Volunteers
- 31 people
- Sponsor
- Gilead Sciences
HIV Infections
Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)
The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors…
- Trial name
- NCT04021290
- Testing
- DTG/3TC FDC, CAR
- Where
- 119 sites in United States, Argentina and 15 more
- Volunteers
- 493 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 Infections
BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV.
- Trial name
- NCT00272779
- Testing
- ATV, RTV, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- 79 sites in United States, Argentina and 27 more
- Volunteers
- 1,057 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment
For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two…
- Trial name
- NCT02227238
- Testing
- DTG, LPV/RTV, Two NRTIs
- Where
- 59 sites in Argentina, Brazil and 11 more
- Volunteers
- 627 people
- Sponsor
- ViiV Healthcare
HIV Infections, Hepatitis C
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and…
- Conditions
- HIV Infections, Hepatitis C, Liver Disease
- Trial name
- NCT00078403
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 333 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection, Human Immunodeficiency Virus, HIV Infections
Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults
GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the treatment of HIV-1 infection in combination with other antiretroviral therapy (ART).
- Trial name
- NCT03045861
- Testing
- GSK2838232, Cobicistat
- Where
- 14 sites in United States, Canada
- Volunteers
- 33 people
- Sponsor
- GlaxoSmithKline
HIV Infections
Safety and Immune Response to Vicriviroc in Combination Regimens in HIV-Infected ART Experienced Children and Adolescents
Complications with current HIV antiretroviral therapy have left many children and adolescents with limited therapeutic options due to drug resistance.
- Trial name
- NCT00766597
- Testing
- Vicriviroc
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 9 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities.
- Trial name
- NCT03784079
- Testing
- GSK3640254
- Where
- 23 sites in United States, France and 4 more
- Volunteers
- 34 people
- Sponsor
- ViiV Healthcare
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
Infection, Human Immunodeficiency Virus
Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)
The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood.
- Trial name
- NCT00920426
- Testing
- GSK1265744 30mg, GSK1265744 5mg
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- ViiV Healthcare
HIV Infections
Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection.
- Trial name
- URBAN (NCT03754803)
- Testing
- HIV symptom distress module (SDM) questionnaire, HIV treatment satisfaction questionnaire (TSQ)
- Where
- 18 sites in Germany
- Volunteers
- 376 people
- Sponsor
- ViiV Healthcare
Acquired Immune Deficiency Syndrome, AIDS
Pilot Study of a Raltegravir Based NRTI Sparing Regimen
This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a…
- Conditions
- Acquired Immune Deficiency Syndrome, AIDS, Human Immunodeficiency Virus, HIV Infections
- Trial name
- NCT00814879
- Testing
- Raltegravir, Atazanavir, Standard treatment regimen
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Yale University
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
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and…
- Trial name
- NCT00460746
- Testing
- TMC125, Darunavir; Ritonavir
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Tibotec, Inc
Infection, Human Immunodeficiency Virus
Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults
GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be…
- Trial name
- NCT00708110
- Testing
- GSK1349572
- Where
- 18 sites in United States
- Volunteers
- 35 people
- Sponsor
- ViiV Healthcare