Clinical trials: HIV-1 Infections
HIV Infection
Safety, Tolerability and Immunogenicity Induced by the THV01 Treatment in Patients Infected With HIV-1 Clade B and Treated With Highly Active Antiretroviral Therapy (HAART).
The objectives of this Phase I/II trial is to evaluate the safety, tolerability and immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly active antiretroviral therapies).
- Trial name
- NCT02054286
- Testing
- THV01-1, THV01-2
- Where
- 11 sites in Belgium, France
- Volunteers
- 38 people
- Sponsor
- Theravectys S.A.
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
Pre-Exposure Prophylaxis of HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or…
- Trial name
- DISCOVER (NCT02842086)
- Testing
- F/TAF, F/TDF
- Where
- 93 sites in United States, Austria and 9 more
- Volunteers
- 5,399 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Human Immunodeficiency Virus-1 (HIV-1) Infection
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy…
- Trial name
- NCT05328583
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- RetroLead (Shanghai) BioPharma Co., Ltd.
HIV-1-infection
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
The goal of this clinical study is to learn more about the experimental drugs lepetegravir (formerly GS-1720) (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and lenacapavir pacfosacil (formerly GS-4182) (a…
- Trial name
- WONDERS2 (NCT06613685)
- Testing
- lepetegravir, lenacapavir pacfosacil, Bictegravir/emtricitabine/tenofovir alafenamide
- Where
- 58 sites in United States, Canada and 7 more
- Volunteers
- 73 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects
The purpose of this study is to confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical…
- Trial name
- NCT00334659
- Testing
- apricitabine
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Avexa
HIV Infections
The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts >= 100 cells/mm3 and an HIV-1 RNA…
- Trial name
- NCT00002379
- Testing
- Indinavir sulfate, Levocarnitine, Adefovir dipivoxil
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Healthy
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection…
- Trial name
- MOSAICO (NCT03964415)
- Testing
- Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine
- Where
- 53 sites in United States, Argentina and 7 more
- Volunteers
- 3,900 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
HIV Infections
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel.
- Trial name
- NCT00303576
- Testing
- dapivirine (TMC120) vaginal gel
- Where
- 4 sites in Rwanda, South Africa and 1 more
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects
To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1 infected pediatric subjects and, if necessary, to…
- Trial name
- NCT00642291
- Testing
- Emtricitabine
- Where
- 2 sites in Romania
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
HIV-1 Infection, Neuropathic Pain
Pregabalin Trial In HIV Neuropathic Pain
This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
- Trial name
- NCT01145417
- Testing
- pregabalin (Lyrica)
- Where
- 29 sites in United States, Colombia and 5 more
- Volunteers
- 217 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
HIV Infections
The Effects of Thymopentin on HIV Infectivity of Blood Cells and Semen in HIV-Infected Patients
Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings in patients infected with…
- Trial name
- NCT00002289
- Testing
- Thymopentin
- Where
- United States
- Sponsor
- Immunobiology Research Institute
HIV Infections
Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
- Trial name
- NCT00106379
- Testing
- Truvada (tenofovir DF + emtricitabine), Emtriva (emtricitabine), Viread (tenofovir DF)
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
There is an unmet medical need for potent ART regimens that make adherence to treatment even easier due to QD dosing, offer a good tolerability profile and fit into the daily life of patients.
- Trial name
- NCT00323687
- Testing
- Truvada
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
HIV Infections
The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.
- Trial name
- NCT00002443
- Testing
- Indinavir sulfate, Zidovudine
- Volunteers
- 780 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV
Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection
The main purpose of this pre-approval access program (PAAP) is to provide rilpivirine Long Acting (RPV LA) injectable suspension for the treatment of human immunodeficiency virus (HIV)-1 infection as single patient request to…
- Trial name
- NCT03847376
- Testing
- Rilpivirine Long Acting (RPV LA)
- Sponsor
- Janssen Sciences Ireland UC
HIV Infections
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
- Trial name
- NCT00002123
- Testing
- Delavirdine mesylate, Didanosine
- Where
- 84 sites in United States, Puerto Rico
- Sponsor
- Pharmacia and Upjohn
HIV Infection
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC125.
- Trial name
- NCT00225303
- Testing
- TMC125
- Volunteers
- 116 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections, Health Volunteers
A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and…
- Trial name
- NCT02990325
- Testing
- ABX464 150mg, ABX464 50mg
- Where
- Spain
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Abivax S.A.
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