Clinical trials: Antivirals/HIV
HIV Infections
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy…
- Trial name
- NCT01302847
- Testing
- DTG film-coated tablets, DTG granules for suspension, DTG dispersible tablets
- Where
- 33 sites in United States, Botswana and 6 more
- Volunteers
- 181 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, HIV
Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
Background: Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects.
- Trial name
- NCT01878799
- Testing
- GS-7977/GS- 5885 FDC
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1 activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at each dose level.
- Trial name
- NCT00352911
- Testing
- VGX-410 (Mifepristone)
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- VGX Pharmaceuticals, LLC
HIV-1
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
- Trial name
- NCT00665847
- Testing
- Etravirine (TMC125), Optimized background regimen (OBR)
- Where
- 42 sites in United States, Argentina and 11 more
- Volunteers
- 103 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly.
- Trial name
- NCT00485264
- Testing
- Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, Raltegravir oral granules for suspension (20 mg/mL)
- Where
- 42 sites in United States, Argentina and 4 more
- Volunteers
- 153 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
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
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion…
- Trial name
- NCT03928821
- Testing
- PGT121, PGDM1400, 10-1074
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each…
- Trial name
- NCT02582983
- Testing
- Enfuvirtide
- Where
- 5 sites in Thailand
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
HIV Infection
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected…
- Trial name
- NCT00040664
- Testing
- ritonavir, fosamprenavir
- Where
- 42 sites in United States, Canada and 5 more
- Volunteers
- 69 people
- Sponsor
- ViiV Healthcare
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
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 Infections
VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1
The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy…
- Trial name
- NCT06214052
- Testing
- VH4524184, Antiretroviral therapy
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 22 people
- Sponsor
- ViiV Healthcare
HIV Infections
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines.
- Trial name
- NCT02463227
- Testing
- VRC01
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
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 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)
HIV Infections, Acquired Immunodeficiency Syndrome
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected…
- Trial name
- NCT00896051
- Testing
- Atazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 50 people
- Sponsor
- Janssen R&D Ireland
HIV Infections
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.
- Trial name
- NCT06061081
- Testing
- VH3739937
- Where
- 18 sites in United States, Argentina and 4 more
- Volunteers
- 21 people
- Sponsor
- ViiV Healthcare