A5315: Romidepsin to awaken HIV

A Phase I/II Study of Single Dose Romidepsin in HIV-infected Adults with Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression

Study Description

A5315 is a study of romidepsin (RMD), a histone deacetylase inhibitor, in HIV-infected participants with undetectable viral load on a protease inhibitor-sparing regimen. The study design is a placebo-controlled, double-blinded, randomized, single administration of RMD in three groups at increasing doses. This study is designed to look at a one-time infusion of RMD to make sure it is safe, easy to take, and to see if it can wake up the hidden or sleeping HIV virus. The amount of virus will be measured using a single copy HIV-1 RNA assay prior to RMD dosing and at other defined time points after starting the RMD dosing. The research site must have the capability to perform and process large amounts of blood cells (leukapheresis).

Treatment Category

Treatment Experienced

Why is this study being done?

The purpose of this study is to identify single doses of RMD that are safe and well-tolerated that can wake up the sleeping or hidden virus so that it will come out of hiding and be attacked or wiped out in an attempt to decrease the HIV reservoir.

Who can join?

  • HIV-infected men and non-pregnant women 18 years of age or older
  • Taking combination anti-HIV therapy that does not include a protease inhibitor or certain other medications (e.g. rilpivirine, cobicistat/elvitegravir)
  • HIV-1 RNA (viral load) less than 50 copies or undetectable for past 24 months
  • CD4+cell count greater than 300
  • Negative for hepatitis B and C infection

What do I need to do in the study?

Each participant will be assigned to one of three groups (depending on when they enter this study) to receive one of three doses. Each group will enroll 15 participants: 12 will receive RMD and 3 will receive a placebo (salt water solution) that does not contain RMD.

  • Group 1: RMD 0.5mg/m2 or placebo
  • Group 2: RMD 2 mg/m2 or placebo
  • Group 3: RMD 5 mg/m2 or placebo

During this study, participants will be seen in the clinic up to 8 times. They will be asked to have three leukapheresis procedures. . Participants may be admitted to the hospital for one night to measure the amount of drug in the blood over time and to measure viral load.

Participants will complete the study in 4 to 8 weeks.

What treatments or drugs are involved with this study?

Romidepsin is approved by the Food and Drug Administration (FDA) to treat cutaneous T-cell lymphoma, a serious type of skin cancer. The drug has not been studied in people with HIV. The doses used in the study are several times lower than those used to treat participants with cancer. Anti-HIV medications are required but not provided by the study.

Study Status: 

Participating ACTG Sites