a study on HIV/AIDS
Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot cure HIV infection because a small amount of virus remains in cells as a hidden (latent) form. The purpose of this study is to evaluate the safety and efficacy of single dose and multiple dose administration of romidepsin (RMD) in HIV-infected adults.
A Phase I/II Study of Romidepsin in HIV-Infected Adults With Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression
A major challenge in eradicating HIV-1 infection is the persistence of virus in long-lived cells, such as latently infected memory CD4 T cells. One approach for eliminating the HIV-1 reservoir is to activate viral replication in these latently infected CD4 T cells by targeting cellular mechanisms that repress proviral transcription. Histone deacetylase inhibitors (HDACis), such as RMD, induce HIV-1 expression by increasing acetylation and facilitating transcriptional activation of HIV-1. RMD administered in combination with ART may serve as an important component of a strategy to eradicate the HIV-1 latent reservoir. The purpose of this study is to evaluate the safety and efficacy of single dose and multiple dose administration of RMD in HIV-infected adults.
Participants will be sequentially enrolled into four cohorts and randomly assigned to receive either RMD or placebo. The cohorts will differ in the dose of RMD given. Participants in Cohorts 1, 2, and 3 will have one intravenous (IV) infusion of RMD or placebo at Day 0. Participants in Cohort 4 will have four IV infusions of RMD or placebo at Days 0, 14, 28, and 42.
For participants in Cohorts 1, 2, and 3, study duration is 4 weeks. For participants in Cohort 4, study duration is a minimum of 24 weeks and a maximum of 48 weeks.
Participants will attend several study visits, which may include a physical examination, blood and urine collection, pharmacokinetic (PK) sampling, and an electrocardiogram (ECG).
HIV Infections Romidepsin
Open to people ages 18 years and up
Cohorts 1, 2, & 3
Cohorts 1, 2, & 3
Inclusion Criteria: Cohort 4, Step 1
Exclusion Criteria: Cohort 4, Step 1
Use of any of the medications listed in the Prohibited Medications table in the protocol
See the protocol for Inclusion and Exclusion Criteria for Cohort 4, Steps 2, 3, and 4.
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01933594.
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