Ongoing Clinical Trials

Title MTN 035
Description The purposes of the study are to find out if men (cis or transgender) and transgender women would accept, tolerate and potentially use three different ways to potentially deliver anti-HIV drugs into the rectum when used before receptive anal sex and to evaluate if each study product is safe when applied rectally and used before anal sex.
Title DC 04
Description This is a study looking to see if a vaccine that is made from a person’s own white blood cells is safe and if it will result in an increase in the body’s immune system reaction to HIV. The study will be done in people living with HIV who are doing well on HIV medications.
Title A5369
Description HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) is a study that will evaluate the safety and effectiveness of a new vaccine in HIV-1 infected persons. This vaccine is not meant to prevent HIV infection but rather to improve how your immune system responds to HIV infection. This study is to evaluate the safety and effectiveness of this vaccine. It is called a therapeutic or treatment vaccine.
Title A5359
Description Long-Acting Antiretroviral Therapy in Non-Adherent Persons Living with HIV is a study for people living with HIV who have poor viremic response or are lost to clinical follow up with ART non-adherence for at least 6 month.  This study uses cash incentives to motivate participants to be adherent with oral meds.  Participants will be randomized to receive long active injectable ART after they are adherent on oral meds.
Title A5377
Description A Phase I, First-in-Human, Ascending Dose Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants with HIV. 

A5377 is the first study in humans of SAR441236.  The study will enroll two groups of people with HIV: Arm A) People who are currently on an anti-HIV regimen with an undetectable HIV viral load will receive either SAR441236 or placebo in one of four increasing dosing groups.  Arm B) People with HIV who have never received anti-HIV medications will receive SAR441236 in one of four increasing dosing groups.  The study will safety and tolerability and collect information about the amount of the antibody in the blood over time.

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

This study is for people who are infected with HIV-1 and have an undetectable viral load. We will evaluate the safety and effectiveness of a combination of two medications. The first drug is called cabotegravir (CAB). This will be given orally at first and then as an injection. The 2nd drug is called VRC-HIVMAB080-00-AB (VRC01LS). This is a monoclonal antibody. A monoclonal antibody targets human proteins rather than attacking the virus directly. This drug will be given intravenous (directly into a vein) for about 15 to 30 minutes. We are studying these medications to see if they work well when taken together to keep your virus levels low. This study will also evaluate the safety of the drug combination.

Division of Infectious Diseases
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Center for Care of Infectious Diseases

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