Clinical trials: HIV -1 Infection
HIV Infection
A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and…
- Trial name
- NCT01717287
- Testing
- Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet, Other Anti-Retroviral Therapy
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.
- Trial name
- NCT05165550
- Testing
- Elsulfavirine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viriom
HIV-1-infection
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy…
- Trial name
- NCT07708727
- Testing
- GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 700 people
- Sponsor
- Gilead Sciences
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-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 the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency…
- Trial name
- CAPELLA (NCT04150068)
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Failing ARV Regimen
- Where
- 75 sites in United States, Canada and 9 more
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
HIV Infections
Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers
Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg compared with placebo in non-HIV-1 infected…
- Trial name
- NCT00648817
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV-1, HIV Infection
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are…
- Trial name
- NCT07862569
- Testing
- DOR/ISL
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV, Human Immunodeficiency Virus
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.
- Trial name
- NCT02175680
- Testing
- PRO 140, Historical data
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- CytoDyn, Inc.
HIV Infections
A Study to Assess the Long-term Efficacy (24 Weeks) of MPC-4326 in Combination With a 2-3 Drug OBR Relative to the Efficacy of a 3-4 Drug ARV Regimen in Treatment Experienced HIV-1 Infected Subjects Who Are Failing Current Antiretroviral Therapy
This phase 2b study is designed to assess the long-term efficacy (24 weeks) of MPC-4326 in combination with a 2-3 drug optimized background regimen (OBR) relative to the efficacy of a 3-4 antiretroviral (ARV) regimen in treatment…
- Trial name
- NCT01026727
- Testing
- MPC-4326 plus a 2-3 drug optimized background regimen (OBR), 3-4 commercially available antiretroviral drugs
- Where
- 25 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Myrexis Inc.
HIV Infections
Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors
The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors.
- Trial name
- NCT00002361
- Testing
- Indinavir sulfate, Ritonavir
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Merck Sharp & Dohme LLC
Human Immunodeficiency Virus
A Safety Study of Brentuximab Vedotin in Participants With HIV
This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment.
- Trial name
- NCT05244473
- Testing
- brentuximab vedotin, ART
- Where
- 2 sites in United States
- Sponsor
- Seagen Inc.
Infection, Human Immunodeficiency Virus I, HIV-1 Infection
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an…
- Trial name
- NCT00242879
- Testing
- Physician determined comparator PI + ritonavir, GW640385 + ritonavir
- Where
- 70 sites in United States, Australia and 9 more
- Volunteers
- 130 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study of CI-1012 in HIV-Infected Patients
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.
- Trial name
- NCT00002196
- Testing
- CI-1012
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Parke-Davis
HIV-1-infection
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and…
- Trial name
- NCT06749054
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR)
- Where
- 9 sites in United States, South Africa
- Volunteers
- 12 people
- Sponsor
- Gilead Sciences
HIV Infections
A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination With Zidovudine (ZDV) Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3
PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients.
- Trial name
- NCT00002124
- Testing
- Delavirdine mesylate, Lamivudine, Zidovudine
- Where
- 88 sites in United States, Puerto Rico
- Volunteers
- 1,250 people
- Sponsor
- Pharmacia and Upjohn
HIV Infections
Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized…
- Trial name
- NCT00056641
- Testing
- tipranavir, ritonavir, saquinavir
- Where
- 109 sites in United States, Australia and 11 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
HIV Infection
TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
This is a Phase II, open-label, roll-over trial to evaluate the long term safety and tolerability of TMC125, administered as part of an individually optimized antiretroviral therapy, in HIV 1 infected subjects.
- Trial name
- NCT00111280
- Testing
- TMC125
- Volunteers
- 48 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland