Clinical trials: Anti-Retroviral Agents
HIV Infection
Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)
This study will examine whether interleukin-2 (IL-2) plus antiretroviral therapy (ART) slows HIV disease progression in patients with low CD4+ T cell counts compared with patients taking ART alone.
- Trial name
- SILCAAT (NCT00013611)
- Testing
- Proleukin
- Where
- United States
- Volunteers
- 1,695 people
- Sponsor
- University of Minnesota
HIV Infections
Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment
The purpose of this study is to test another way to control the amount of HIV in the blood (viral load). Studies show that stopping all anti-HIV drugs for a time before switching to new anti-HIV drugs may improve the response in…
- Trial name
- NCT00011128
- Testing
- Antiretroviral Treatment Interruption
- Where
- 30 sites in United States, Puerto Rico
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HAART-induced Lipodystrophy and Metabolic Syndrome
Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy…
- Trial name
- NCT00140244
- Testing
- r-metHuLeptin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Beth Israel Deaconess Medical Center
Infection, Human Immunodeficiency Virus I, HIV Infection
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.
- Trial name
- NCT00044577
- Testing
- abacavir/lamivudine, abacavir, lamivudine
- Where
- 76 sites in United States, Belgium and 7 more
- Volunteers
- 166 people
- Sponsor
- ViiV Healthcare
Healthy Volunteers
Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour Area Under the Curve (AUC) and Cmax as the primary comparison measures in…
- Trial name
- NCT01136928
- Testing
- American ginseng
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV-1-infection
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
- Trial name
- NCT06987318
- Testing
- VRC07-523LS, PGT121.414.LS
- Where
- 13 sites in United States, Brazil and 1 more
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Renal Disease
Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies
Renal outcome could be different after switching tenofovir to different antiretroviral strategies, in case of renal toxicity. Therefore, it is necessary to evaluate the importance of renal evolution in these patients, in terms of…
- Trial name
- TDFOUT (NCT02209740)
- Testing
- Tenofovir switch
- Where
- Spain
- Volunteers
- 245 people
- Sponsor
- Asociacion para el Estudio de las Enfermedades Infecciosas
HIV
Dolutegravir in Reservoirs
The purpose of this study is to find out how well the HIV medication dolutegravir gets into different parts of the body including blood plasma, special blood cells, and rectal tissue.
- Trial name
- NCT02924389
- Testing
- dolutegravir, Triumeq, Truvada
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Emory University
HIV Infections
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
- Trial name
- NCT00504452
- Testing
- KP-1461
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Koronis Pharmaceuticals.
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, Inflammation
CC-11050 in Human Immunodeficiency Virus-1-Infected Adults With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE)
Background: When there is a threat to the body, the immune system triggers inflammation. Too much inflammation can damage the body or cause painful symptoms.
- Trial name
- NCT02652546
- Testing
- Assess Safety, Effect of drug on viral load, Effect of drug on T-cell count
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic HIV Infection
The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage Antibodies
This is a multicenter controlled interventional trial. This phase 1 trial is the first study to assess 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + aluminum hydroxide suspension (Alum) in people living with HIV (PLWH).
- Trial name
- NCT06006546
- Testing
- 426c.Mod.Core-C4b, Adjuvant 3M-052-AF+Alum
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Seropositivity, Adherence, Medication
Supporting Health Behavior Among Persons Living With HIV Using Tech, MOST, and Behavioral Economics
The present study focuses on adult persons living with HIV in the New York City and Newark, New Jersey metropolitan areas who are not highly adherent to HIV medication and who do not evidence undetectable HIV viral load (the…
- Trial name
- SCAP2 (NCT04518241)
- Testing
- MI sessions, TMQQ, Type of compensation
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- New York University
HIV Infections
Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients
The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.
- Trial name
- NCT00002375
- Testing
- Indinavir sulfate, Nelfinavir mesylate
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Antiretroviral Therapy (ART) Adherence, PMTCT
Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania
The goal of this clinical trial is to find better ways to care for pregnant and postpartum adolescent girls and young women (AGYW) aged 15-24 years with HIV in Tanzania, and to prevent them from passing HIV to their babies.
- Conditions
- HIV Antiretroviral Therapy (ART) Adherence, PMTCT, Pregnancy, Retention in Care
- Trial name
- ENGAGE (NCT06605053)
- Testing
- Co-produced intervention to optimize PMTCT care engagement
- Where
- 2 sites in Tanzania
- Volunteers
- 222 people
- Sponsor
- Karolinska Institutet
HIV Infections
A Study of Peldesine (BCX-34) in HIV-Infected Patients
The purpose of this study is to determine the highest amount of peldesine that is safe. This study will also see if this amount of peldesine is effective in lowering HIV levels in the blood.
- Trial name
- NCT00002237
- Testing
- Peldesine
- Where
- United States
- Sponsor
- BioCryst Pharmaceuticals
HIV Infections, Obesity
Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain
The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others.
- Trial name
- NCT05463783
- Testing
- Biktarvy, Symtuza
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- East Carolina University
Hiv
Postpartum Adherence Clubs for Antiretroviral Therapy
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+").
- Trial name
- PACART (NCT03200054)
- Testing
- Adherence Clubs
- Where
- South Africa
- Volunteers
- 412 people
- Sponsor
- University of Cape Town
Human Immunodeficiency Virus (HIV) Prophylaxis
Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women
This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC)…
- Trial name
- NCT02431273
- Testing
- TDF IVR, TDF-FTC IVR, TDF-FTC-MVC IVR
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Auritec Pharmaceuticals
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