A5128: US Genomic Sampling
About:
Study Requirements:
- Anyone enrolled in an ACTG study
Contact:
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
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.
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
Antibodies that develop naturally against HIV recognize and attach to one part of the virus so that the bodyβs immune system can try to attack it. Antibodies are usually made by a personβs 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 Aβpeople 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 Bβpeople who have never received anti-HIV medications will receive SAR441236 in four increasing dosing groups.
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
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.
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765
π§ ResearchWithAHeart@njms.rutgers.edu
π 1 (844) 782-6765