Clinical trials: HIV1 Infection
HIV-1
Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1 Ribozyme [OZ1]) as part of an earlier phase 2…
- Trial name
- NCT01177059
- Testing
- OZ1 transduced cells
- Where
- 6 sites in United States, Australia
- Volunteers
- 68 people
- Sponsor
- Janssen-Cilag Pty Ltd
HIV-1-infection
Therapeutic Vaccination in Treated HIV Disease
The central premise of our program is that durable control of HIV in the absence of antiretroviral therapy ("remission") will require the generation of de novo potent and sustained HIV-specific CD8+ cell responses that target…
- Trial name
- NCT03606213
- Testing
- PENNVAX-GP, INO-6145, INO-9012
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Steven Deeks
HIV Infections
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from >=3 to <18 years of age.
- Trial name
- NCT00905489
- Testing
- Nevirapine Immediate Release (IR), Nevirapine Extended Release (XR)
- Where
- 10 sites in United States, Botswana and 2 more
- Volunteers
- 85 people
- Sponsor
- Boehringer Ingelheim
HIV-1 Infection
Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC…
- Trial name
- NCT02469246
- Testing
- F/TAF, ABC/3TC, 3rd ARV agent
- Where
- 80 sites in United States, Belgium and 10 more
- Volunteers
- 567 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable…
- Trial name
- SIMPLE (NCT02581202)
- Testing
- lopinavir/ritonavir, lamivudine
- Volunteers
- 216 people
- Sponsor
- AbbVie
Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV.
- Conditions
- Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
- Trial name
- NCT00099359
- Testing
- Zidovudine, Nevirapine (NVP), Epivir (3TC)
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 1,735 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HIV-1 Infection
Islatravir and Methadone Pharmacokinetics (MK-8591-029)
The present study is designed to determine the effect of islatravir (ISL) [MK-8591] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve…
- Trial name
- NCT04568603
- Testing
- Islatravir
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
The goal of this clinical study is to learn more about the impact of cobicistat (COBI) (P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and strong cytochrome P450 enzyme [CYP]3A inhibitor), voriconazole (VOR)…
- Trial name
- NCT05458102
- Testing
- Vesatolimod, Cobicistat, Voriconazole
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Gilead Sciences
HIV-1-infection
INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV
This is an unblinded cluster-randomized study to evaluate the effectiveness of two strategies for scripting/dispensing of antiretroviral therapy (ART) on retention, virologic suppression, and cost compared to the standard of…
- Trial name
- INTERVAL (NCT03101592)
- Testing
- Three-month ART dispensing, Six-month ART dispensing
- Where
- 2 sites in Malawi, Zambia
- Volunteers
- 9,118 people
- Sponsor
- University of California, Los Angeles
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 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-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
Infection, Human Immunodeficiency Virus
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or…
- Trial name
- FLAMINGO (NCT01449929)
- Testing
- dolutegravir 50 mg OAD, darunavir 800mg OAD, ritonavir 100mg OAD
- Where
- 66 sites in United States, France and 7 more
- Volunteers
- 488 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection
- Trial name
- NCT04003103
- Testing
- Islatravir
- Where
- 9 sites in United States, Israel and 1 more
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the…
- Trial name
- NCT00530920
- Testing
- tipranavir, ritonavir
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 85 people
- Sponsor
- Boehringer Ingelheim
Human Immunodeficiency Virus (HIV)
Romidepsin Plus 3BNC117 Phase 2a Study
The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals during an analytical interruption of ART.
- Trial name
- ROADMAP (NCT02850016)
- Testing
- 3BNC117, Romidepsin
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 48 people
- Sponsor
- Rockefeller University
HIV-1-infection, COVID-19
HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
HIV CoCo is a European multi-centre, multi-country, retrospective, observational case-control study that will aim to describe clinical outcomes and identify risk factors for People Living With HIV (PLWHIV) who are co-infected…
- Trial name
- HIV CoCo (NCT05481216)
- Testing
- COVID-19, HIV-1 infection
- Where
- 23 sites in Belgium, France and 3 more
- Volunteers
- 2,598 people
- Sponsor
- NEAT ID Foundation
HIV-1 Infections
Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China
This post-marketing observational study is conducted for obtaining data on clinical, biological and virological outcomes, compliance and tolerability of using a lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of…
- Trial name
- NCT01074931
- Testing
- Lopinavir/ritonavir (Kaletra)
- Where
- 5 sites in China
- Volunteers
- 98 people
- Sponsor
- Abbott
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
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