Study of Valproic Acid to Treat HIV Infected Adults

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A histone deacetylase (HDAC) inhibitor is a class of drug that interferes with the function of HDAC, an enzyme that hides HIV within inactive CD4 cells. These drugs are normally used to treat seizures and other nervous system problems but have been found to work against HIV. The purpose of this study is to investigate the efficacy of valproic acid (VPA), an HDAC inhibitor, in treating HIV infected adults using anti-HIV drugs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Enfuvirtide; Valproic Acid

Criteria

Inclusion Criteria:

• HIV-1 infected

• Adherent to current HAART regimen

• Adequate vascular access for leukapheresis

• Receiving HAART, defined as at least two nucleoside reverse transcriptase inhibitors plus at least one protease inhibitor or non-nucleoside reverse transcriptase inhibitor, without changes to the regimen within 24 weeks of study entry

• Viral load more than 50 copies/ml on two consecutive occasions for more than 6 months, and less than 200 copies/ml on occasion for more than 6 months prior to study entry

• CD4 count more than 300 cells/mm3

• Willing and able to comply with all study requirements

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• Currently receiving zidovudine or enfuvirtide

• Require certain medications known to interact with valproate (e.g., lamotrigine; barbiturates; carbamazepine; prescription dosages of salicylates, hydantoins, felbamate, and clonazepam)

• Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.

• Contraindications to taking VPA (e.g., pregnancy, bleeding disorders, history of pancreatitis, history of hepatitis)

• Receiving interferon, other immunomodulators, or other experimental medications

• Abnormal liver enzyme tests

• Hepatitis B virus infected

• Symptoms of hepatic decompensation

• Blood transfusions or hematopoietic growth factors within 90 days prior to study entry

• Systemic cytotoxic chemotherapy, investigational agents, or immunomodulators within 90 days prior to study entry

• Current drug or alcohol abuse that, in the opinion of the site investigator, would interfere with the study

• Serious illness requiring systemic treatment or hospitalization within 90 days prior to study entry

• Treatment for a current AIDS-defining opportunistic infection within 90 days prior to screening

• Anemic

• Involuntarily incarcerated for treatment of either a psychiatric illness or physical illness (e.g., infectious disease)

• Pregnancy or breastfeeding