University of Southern California CRS

Site Details

LOCATION

5P21 Rand Schrader Clinic

1300 North Mission Road

Room 349

Los Angeles, CA. 90033-1079

323-343-8288

Get Directions

Site Type

CRS

CRS Coordinator

Luis Mendez

lmendez@usc.edu

323-409-8283

CRS Leader

Michael Dube

mdube@usc.edu

317-630-6119

Site Trials

HIV Cure

Open and enrolling

A5341s: Intensive Reservoir Sampling, A5321 Substudy

A5341s: A5321 Sampling Substudy

 

Longitudinal Sampling Substudy of A5321 is collecting information from measures of different HIV reservoirs, including where HIV can be found, whether different reservoirs have different amounts of HIV, the best way is to measure the amount of HIV in different reservoirs, and whether the amount of HIV found in one reservoir says anything about the amount of HIV in other reservoirs.

See More Info on A5321 to learn more.

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

A5321: Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study

Studies differences and changes over time in HIV reservoirs (groups of HIV infected cells that ’hide’ from anti-HIV medications).  

HIV (and comorbidities)

Open and enrolling

A5128: US Genomic Sampling

Designed to develop a standard operating procedure to establish a storage bank for specimens for future HIV DNA analyses.

Informed consent to use stored specimens for currently unspecified/ genetic analyses.

HIV (and comorbidities)

Active, Not Recruiting

A5357: A Study of Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) to Maintain Viral Suppression in Adults Living with HIV-1

This study is for people with HIV who have an undetectable viral load. The study will evaluate the safety and effectiveness of a combination of two medications. The first drug is called long-acting cabotegravir (CAB), which will be given orally during Part 1 of the study and then as an injection every 4 weeks during Part 2 of the study. The second drug is called VRC07-523LS, which is a monoclonal antibody. A monoclonal antibody targets human proteins rather than attacking the virus directly. This drug will be given intravenously (directly into a vein) over about 15 to 30 minutes every 8 weeks.

 

Hepatitis

Active, Not Recruiting

A5368:Anti-PD-1 Antibody in HBV Infected on Suppressive Antiviral Therapy

“Safety and Immunotherapeutic Activity of Cemiplimab in Participants with HBV on Suppressive Antiviral Therapy: A Phase I/II Ascending Multiple Dose Study”

Scientists are looking at ways to cure Hepatitis B (HBV). This study will assess the safety and tolerability of cemiplimab administered in participants with HBV on suppressive antiviral therapy.

HIV (and comorbidities)

Closed to accrual

A5322: Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation (HAILO)

You are being asked to take part in this research study because you are infected with HIV, the virus that causes AIDS, and were previously followed in the ALLRT (A5001) study and are 40 years of age or older. This study, A5322 (also known as the HAILO study), is a long-term follow-up study of persons who have HIV and received their first treatment for HIV known as antiretroviral medications, in certain clinical trials that were done by the AIDS Clinical Trials Group (ACTG).

 

HIV (and comorbidities)

Closed to accrual

A5332: REPRIEVE Trial

In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.

HIV (and comorbidities)

Closed to accrual

A5361s: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

Aging with HIV may be associated with an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that the class of drugs called statins, such as pitavastatin, might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle, or by decreasing inflammation markers in the blood. This study uses the REPRIEVE Trial (A5332) and the REPRIEVE Mechanistic Substudy (A5333s) to study the impact of pitavastatin on muscle.

HIV (and comorbidities)

Closed to accrual

A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease.  NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack).  In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism.  Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.

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.

Mpox

Open and enrolling

A5418:Study of Tecovirimat for Human Monkeypox Virus (STOMP)

A5418 (STOMP) is a study of tecovirimat (also known as TPOXX) for the treatment of human monkeypox virus (HMPXV) disease.