Clinical trials: HIV -1 Infection
HIV-1 Infections
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo…
- Trial name
- NCT00799058
- Testing
- dapivirine 4789, dapivirine gel 4759
- Where
- 5 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1 Infection
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination…
- Trial name
- NCT03405935
- Testing
- B/F/TAF
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 86 people
- Sponsor
- Gilead Sciences
HIV Infections
Safety, Tolerance, Pharmacokinetic and Antiviral Study of Amdoxovir in Combination With Zidovudine in Adults With HIV
The purpose of this study is to determine the short term safety, tolerance, and antiviral effect of zidovudine (AZT) and amdoxovir (AMDX, DAPD) in combination, and whether the dosage for AZT can be reduced, potentially decreasing…
- Trial name
- NCT00432016
- Testing
- zidovudine, amdoxovir, pharmacokinetic sampling
- Where
- Argentina
- Volunteers
- 24 people
- Sponsor
- RFS Pharma, LLC
HIV Infections
Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and…
- Trial name
- NCT03984812
- Testing
- GSK3732394
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load…
- Trial name
- NCT00531206
- Testing
- Tipranavir, Ritonavir
- Where
- 27 sites in Germany
- Volunteers
- 65 people
- Sponsor
- Boehringer Ingelheim
HIV-1 Infection in Adults (Asymptomatic)
Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to…
- Trial name
- NCT01140126
- Testing
- Antibody UB-421
- Where
- 2 sites in Taiwan
- Volunteers
- 20 people
- Sponsor
- United Biomedical
Chronic Hepatitis B
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
- Trial name
- NCT02589457
- Testing
- CKD-390, Viread® tablet
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Chong Kun Dang Pharmaceutical
HIV Infections
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
- Trial name
- SOLAR (NCT04542070)
- Testing
- Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets
- Where
- 117 sites in United States, Australia and 12 more
- Volunteers
- 687 people
- Sponsor
- ViiV Healthcare
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Human Immunodeficiency Virus (HIV)
Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439A) 100 mg +…
- Trial name
- DRIVE-AHEAD (NCT02403674)
- Testing
- Doravirine, Tenofovir, Lamivudine, ATRIPLA™
- Volunteers
- 734 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors [NRTIs]) are at risk for the development of a mutation at…
- Trial name
- Resistance (NCT00312039)
- Testing
- Elvucitabine, Lamivudine
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV Infections
Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.
- Trial name
- NCT00004852
- Testing
- Efavirenz, Lamivudine, Zidovudine
- Where
- 66 sites in United States, Argentina and 3 more
- Sponsor
- Glaxo Wellcome
HIV
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140…
- Trial name
- NCT02859961
- Testing
- PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg)
- Where
- 12 sites in United States
- Volunteers
- 562 people
- Sponsor
- CytoDyn, Inc.
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human…
- Trial name
- VOYAGE-1 (NCT03222583)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 48 sites in China, Singapore and 1 more
- Volunteers
- 546 people
- Sponsor
- AbbVie
Cytomegalovirus Retinitis, HIV Infections
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients.
- Trial name
- NCT00002437
- Testing
- Cidofovir, Probenecid
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients
This is a phase I, open-label, dose-escalation study to investigate short-term safety, pharmacokinetics, and antiviral activity of UB-421 SC with 4 weekly doses in treatment naive HIV-1 infected patients.
- Trial name
- NCT04620304
- Testing
- UB-421 SC(dB4C7C22-6 mAb)
- Where
- Taiwan
- Volunteers
- 15 people
- Sponsor
- United BioPharma
HIV Infections
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.
- Trial name
- NCT00002436
- Testing
- Lamivudine, Zidovudine, Zalcitabine
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 325 people
- Sponsor
- Glaxo Wellcome
Infection, Human Immunodeficiency Virus, HIV Infections
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects.
- Trial name
- NCT01641809
- Testing
- GSK1265744 10 mg, GSK1265744 30 mg, GSK1265744 60 mg
- Where
- 48 sites in United States, Canada
- Volunteers
- 244 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus I, HIV Infection
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone.
- Trial name
- NCT00257621
- Testing
- GW640385, Ritonavir
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine
- Trial name
- NCT00850616
- Testing
- V526
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC