A5315

Emory-CDC HIV/AIDS Clinical Trials Unit

                  AIDS Clinical Trials Group (ACTG): ACTG A5315

                         

Title of Study: 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

Brief Description:

A5315 is a phase I/II, double-blinded, randomized, placebo-controlled, dose-escalation study to evaluate the safety and efficacy of a single dose administration of romidepsin (RMD). Three cohorts (1-3) of 15 subjects each will be sequentially enrolled into the study (depending on safety outcomes, which will determine whether to dose escalate or not). Toxicity related to the administration of RMD will be evaluated systematically

Inclusion/ Exclusion Criteria:

 

Abbreviated List of Inclusion/Exclusion Criteria                         

Inclusion:

  • Taking  antiretroviral therapy (ART) that includes a raltegravir, dolutegravir, or efavirenz-based regimen
  • HIV-1 RNA (viral load) < 50 copies/ml for past 24 months
  • CD4+cell count > 300 cells/mm3
  • Men and non-pregnant women age >18 years
  • Good veins to draw blood from in both arms
  • Agree to follow a strict visit schedule
  • (Leaukapheresis x 3, and 24-48 hours stay in Emory’s ACTSI unit)
  • Agree to follow birth control requirements

Exclusion:

  • PI base regimens
  • History of or current cytomegalovirus (CMV) end organ disease (eg, retinitis).
  • History of seizure disorders.
  • HBsAG positive

Treatment:

Subjects will be sequentially enrolled to each cohort and randomized 4:1 to receive RMD or placebo:

  • Cohort 1:         12 subjects (0.5 mg/m2 RMD in 0.9% saline)

3 subjects (placebo in 0.9% saline)

  • Cohort 2:         12 subjects (2 mg/m2 RMD in 0.9% saline)

3 subjects (placebo in 0.9% saline)

  • Cohort 3:         12 subjects (5 mg/m2 RMD in 0.9% saline)

3 subjects (placebo in 0.9% saline)

For more information contact:

Ericka R. Patrick, RN, MSN

404-616-6313

erpatri@emory.edu