NCT00289952

Valproic Acid and Its Effects on HIV Latent Reservoirs

Use of Valproic Acid to Purge HIV From Resting CD4+ Memory Cells/ A Proof-of-concept Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Jean-Pierre Routy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine whether the co-administration of valproic acid (Epival®), with highly active antiretroviral therapy (HAART) can reduce the size of HIV latent reservoirs in infected CD4 cells.

Detailed description

Participants must be on HAART with a suppressed viral load (\< 50 copies/ml) for at least the previous 12 months. They will be randomly assigned to one of two groups, one group will start the valproic acid right away at week 1 for 16 weeks, and the other group will wait until week 17 to add valproic acid to their treatment for 32 weeks. Subjects will be followed every four weeks for one year and evaluated by a variety of assays, all carried out using well-established methods, to assess the main outcome defined by changes in HIV reservoir size measured by the mean frequency of resting CD4 memory cells carrying HIV proviral DNA.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Valproic Acid	Oral valproic acid twice daily for 16 or 32 weeks. Dosage varies based on plasma levels.
DRUG	HAART	As per standard of care.

Timeline

• Start date: 2006-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2006-02-10
• Last updated: 2023-03-15

Locations

6 sites across 1 country: Canada