MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4+ T Cell HIV Infection

Phase 2 Terminated 6 enrolled University of North Carolina, Chapel Hill Abbott · collab Merck Sharp & Dohme LLC · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments. We will see if adding Raltegravir (MK-0518) and Valproic acid (VPA) to current ART can decrease the amount of latent HIV.

Timeline

Start: 2007-04
Primary completion: 2008-09
Completion: 2008-09

Outcome

Missed primary endpoint

Stopped (Business): “Due to insufficient funds”

paper VPA and RAL, VPA and ENF, or ENF failed to progressively reduce the frequency of RCI PMID 20186346 ↗

Publications

Results Archin NM, Cheema M, Parker D, Wiegand A, Bosch RJ, Coffin JM, Eron J, Cohen M, Margolis DM. Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection. PLoS One. 2010 Feb 23;5(2):e9390. doi: 10.1371/journal.pone.0009390.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Raltegravir	Other / unclassified	400 mg	Oral
Subject	Valproic Acid	Small molecule	1000 mg	—
Subject	Valproic Acid	Small molecule	2000 mg	—