Clinical trials: HIV -1 Infection
AIDS, AIDS Vaccines
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
The purpose of this study is to investigate a combined set of parameters deemed to impact the quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral therapy-naïve HIV-1 infected subjects.
- Trial name
- NCT01610427
- Testing
- Blood sample collection
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
HIV Infections
A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
- Trial name
- NCT00002442
- Testing
- Indinavir sulfate, Nelfinavir mesylate, Lamivudine
- Where
- 12 sites in United States
- Sponsor
- Glaxo Wellcome
HIV-1 Infection
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
- Trial name
- NCT04406727
- Testing
- UB-421, Antiretroviral (ARV)
- Volunteers
- 50 people
- Sponsor
- United BioPharma
Human Immunodeficiency Virus (HIV) Infections
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)
The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for…
- Trial name
- NCT05130086
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV I Infection
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal…
- Trial name
- NCT00659789
- Testing
- Vacc-4x, Sterile water
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 137 people
- Sponsor
- Bionor Immuno AS
HIV Infections
An Observational Study of Induction Therapy With Fuzeon (Enfuvirtide) in Combination With Antiretroviral Drugs in Patients With HIV-1 Infection
This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1…
- Trial name
- NCT01902615
- Where
- Spain
- Volunteers
- 58 people
- Sponsor
- Hoffmann-La Roche
Human Immunodeficiency Virus Type 1
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF)…
- Trial name
- NCT02269917
- Testing
- D/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF
- Where
- 79 sites in United States, Belgium and 8 more
- Volunteers
- 1,149 people
- Sponsor
- Janssen R&D Ireland
HIV Infections
Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients
Objectives of the study were to evaluate the efficacy and safety of two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI combination of saquinavir (SQV) and ritonavir…
- Trial name
- NCT02239835
- Testing
- Tipranavir (TPV) low dose, Tipranavir (TPV) high dose, Ritonavir low dose
- Volunteers
- 79 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies
The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected children and babies.
- Trial name
- NCT00002210
- Testing
- Delavirdine mesylate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Pharmacia and Upjohn
HIV-1 Infection
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg…
- Trial name
- NCT00534352
- Testing
- TMC125; darunavir; ritonavir
- Volunteers
- 23 people
- Sponsor
- Tibotec, Inc
HIV-1-infection
Open Labelled, Randomized Study to Evaluate the Efficacy, Safety and Dose Selection of VM-1500A-LAI Drug in HIV-infected Patients Transferred From Previous Stable Therapy (NNRTI + 2NRTI), Including ELPIDA®
Open labelled, randomized study to evaluate the efficacy, safety and dose selection of VM-1500A-LAI drug in HIV-infected patients transferred from previous stable therapy (NNRTI + 2NRTI), including ELPIDA®.
- Trial name
- NCT05163535
- Testing
- VM-1500A-LAI, ELPIDA®
- Where
- 2 sites in Russia
- Volunteers
- 36 people
- Sponsor
- Viriom
HIV Infections
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)
This protocol represents the third in human study of TUTI-16, and is being conducted to gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.
- Trial name
- NCT01335191
- Testing
- TUTI-16 (1.0 mg)
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Thymon, LLC
Human Immunodeficiency Virus
Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.
- Trial name
- NCT02808949
- Testing
- Dapivirine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infection
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a…
- Trial name
- NCT04223778
- Testing
- DOR/ISL, ART
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 672 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3
The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+…
- Trial name
- NCT00001993
- Testing
- Butyldeoxynojirimycin, Zidovudine
- Where
- 6 sites in United States
- Volunteers
- 120 people
- Sponsor
- G D Searle
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
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects
The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg…
- Trial name
- NCT00146328
- Testing
- Tipranavir
- Where
- 233 sites in United States, Argentina and 16 more
- Volunteers
- 997 people
- Sponsor
- Boehringer Ingelheim
HIV, HIV Infections
Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350…
- Trial name
- NCT00869557
- Testing
- Stribild, Atripla
- Where
- 30 sites in United States
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
HIV Infections
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.
- Trial name
- NCT00002353
- Testing
- P3C541b Lipopeptide
- Where
- United States
- Sponsor
- United Biomedical
HIV Infections
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM)…
- Trial name
- NCT04371380
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir extended release suspension for injection (long-acting)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare