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A5128: US Genomic Sampling

About:

This study is designed to develop a standard operating procedure to establish a storage bank for specimens for future HIV DNA analyses.

Study Requirements:

  • Anyone enrolled in an ACTG study

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

A5357: A Study of Long-Acting Cabotegravir Plus VRC01LS to Maintain Viral Suppression in HIV-1-Infected Adults

About:

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 at first and then as an injection every 4 weeks. The second drug is called VRC-HIVMAB080-00-AB (VRC01LS), 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, intravenous [or β€œIV”]) for about 15 to 30 minutes every 12 weeks.

Study Requirements:

  • People living with HIV
  • Ages 18 and older
  • On stable anti-HIV medications for a minimum of 8 weeks
  • With a CD4+ cell count greater than or equal to 350
  • Having an undetectable HIV viral load (less than 40 copies)
  • With no current Hepatitis B or C infection
  • With no history of seizures or treatment for seizures within the past 2 years
  • With a susceptibility to VRC01LS based on assay done at screening

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

A5359: The LATITUDE Study

About:

This study is investigating whether long-acting injectable medications will be more successful for people who are non-adherent to their HIV medications than oral regimens.

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 study-provided 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 ART 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 oral SOC ART for 52 weeks.

Study Requirements:

  • People living with HIV
  • Ages 18 and older
  • Have an HIV viral load greater than 200 copies
  • Show evidence of non-adherence to their HIV medications by either:
    • Poor virologic response within the last 18 months (viral load greater than 200 copies at two time points at least 4 weeks apart)
    • Loss to clinical follow-up within the last 18 months, with ART non-adherence for at least 6 consecutive months
  • Have no active hepatitis B or C
  • Are willing to receive injections in the gluteus muscles (buttocks).

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

A5377: Tri-specific Antibody

About:

Antibodies that develop naturally against HIV recognize and attach to one part of the virus so that the body’s immune system can try to attack it. Antibodies are usually made by a person’s own immune system, but they can also be manufactured as a drug. SAR441236 has been manufactured to attach to three parts of the HIV virus at the same time, and to neutralize (or block) the ability of the virus to infect more cells.

A5377 is the first study of SAR441236 in humans. This study will enroll two groups of people with HIV: Arm Aβ€”people who are on an anti-HIV regimen with an undetectable HIV viral load will receive either SAR441236 or placebo in four increasing dosing groups; and Arm Bβ€”people who have never received anti-HIV medications will receive SAR441236 in four increasing dosing groups.

Study Requirements:

  • People living with HIV
  • Ages 18-70 years
  • No active Hepatitis B or C infection

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

A5379: B-Enhancement of HBV vaccination in persons living with HIV (BEe-HIVe): Evaluation of HEPLISAV-B

About:

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.

Vaccination for hepatitis B in individuals living with HIV does not always work, especially in those with impaired immune systems or ability to fight infection. Prevention of hepatitis B in individuals living with HIV has primarily been done by vaccinating with a series of 3 shots given over 6 months. A new vaccine, called HEPLISAV-B, has been approved that may provide a better response than what has currently been used. The researchers will study whether this vaccine will prove to be more effective than the current standard.

Study Requirements:

  • People living with HIV
  • Been on HIV treatment for more than 56 days
  • Previously received vaccines for hepatitis B, but the vaccines didn’t work
  • There will be a small group of participants (73) who have never been vaccinated for hepatitis B
  • CD4 cell count (the number of white blood cells that fight infection) more than 100
  • HIV viral load (how much HIV is in the body) less than 1000
  • In the group vaccinated with the hepatitis B vaccine, the vaccination was over 168 days ago

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

EXIT-CJS

About:

The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

Merck 022

About:

This study will evaluate whether oral Islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenovir disproxil fumarate (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.

Study Requirements:

  • HIV negative
  • 18-45 years old
  • Assigned female sex at birth and is cisgender
  • Not be pregnant or breastfeeding for the duration of the study

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765


 

Merck 024

About:

The main purpose of the study is to evaluate the efficacy and safety of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization. The primary hypothesis of the study is that the administration of ISL QM as PreP reduces the incidence rate per year of the confirmed HIV-1 infections compared to the background incidence rates.

Study Requirements:

  • HIV negative
  • 18 years or older
  • Identify as a man who has sex with men, and/or identify as gender-variant/non-conforming

Contact:

πŸ“§ ResearchWithAHeart@njms.rutgers.edu
πŸ“ž 1 (844) 782-6765