Site Details
LOCATION
Site Type
CRS
Site Trials
HIV (and comorbidities)
Open and enrolling
A5415: A Limited-Center, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living with HIV
The purpose of this study is to see if cenicriviroc mesylate (or CVC) can reduce inflammation of the arteries (the blood vessels that carry blood from the heart through the body) in people living with HIV (human immunodeficiency virus) (the virus that causes acquired immune deficiency syndrome [AIDS]). This study will also look at how safe CVC is when it is taken by people living with HIV who are taking anti-HIV medications.
COVID-19
Open and enrolling
HIV (and comorbidities)
Open and enrolling
A5359: Long-Acting Antiretroviral Therapy in Non-adherent Persons Living with HIV (PLWH)
This four-step study compares Long-Acting (LA) Injectable Antiretroviral Therapy (ART) to standard of care (SOC) oral ART in previously non-adherent individuals.
· Step 1 is the induction phase and all participants receive SOC oral ART. Participants receive financial incentives for meeting study-specified goals.
· Step 2 is the randomization phase and participants are randomized 1:1 to receive LA injectable ART (cabotegravir and rilpivirine injections) or continue on SOC for 52 weeks.
· Step 3 is the crossover/continuation phase. Participants randomized to LA ART will continue that therapy, and eligible SOC participants will cross-over to receive LA ART for 52 weeks.
· Step 4 is the observational phase that switches participants who received at least one LA ART injection and are no longer eligible for injections back to locally sourced SOC oral ART for 52 weeks.
HIV Cure
Open and enrolling
HIV (and comorbidities)
Open and enrolling
Hepatitis
Closed to accrual
A5379: B-Enhancement of HBV vaccination in persons living with HIV (BEe-HIVe): Evaluation of HEPLISAV-B
A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.
HIV (and comorbidities)
Open and enrolling
A5391: Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)
Weight gain after starting HIV therapy is common, but recent studies have found that some people with HIV (PWH) who are taking an integrase inhibitor (INSTI) combined with a tenofovir alafenamide (TAF) regimen may gain more weight than people taking other drug combinations. A rising number of PWH are overweight or obese, and a higher body mass index (BMI) increases the risk for diabetes, heart disease and stroke.
This study will include PWH who have been virally suppressed on a regimen consisting of an integrase inhibitor (INSTI) and TAF/FTC or TAF/3TC, and have a BMI of 30 kg/m2 (the cut-off for obesity) or greater. This research study is trying to find out if they could gain less weight, or maybe lose weight, after switching to a regimen containing doravirine (DOR) with TAF/FTC (or TAF/3TC), or DOR with the related medication tenofovir disproxil (TDF/FTC [or TDF/3TC]) as compared to continuation of their current INSTI plus TAF regimen.
HIV Cure
Open and enrolling
A5386: N-803 with or without bNAbs for HIV-1 control in participants living with HIV-1 on suppressive ART
Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is “asleep” and is also thought to increase the body’s natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body’s immune response to HIV. N-803 alone or in combination with bNAbs may provide greater control of HIV than previous efforts.
HIV (and comorbidities)
Closed to accrual
ACTG A5383: Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)
This study will include 180 participants. Participants will have HIV and Cytomegalovirus (CMV). CMV is common virus that many people living with and without HIV have been exposed to. You do not need to know if you have CMV to be considered for study participation. About half of the study participants will be given study medication to be taken once daily for 48 weeks. The study medication will be letermovir, an FDA approved medication to prevent CMV. The other half of
participants will not receive any additional medication. The study will last about 1 year and 2 months.
Mpox