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Sponsors and Collaborators: |
McGill University Health Center Canadian Foundation for AIDS Research (CANFAR) Canadian HIV Trials Network |
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Information provided by: | McGill University Health Center |
ClinicalTrials.gov Identifier: | NCT00289952 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Valproic Acid Drug: HAART |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Use of Valproic Acid to Purge HIV From Resting CD4+ Memory Cells/ A Proof-of-Concept Study |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
HAART + valproic acid for 16 weeks followed by HAART alone for 32 weeks.
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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.
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Group 2: Experimental
HAART alone for 16 weeks followed by HAART + valproic acid for 32 weeks.
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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.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented HIV seropositive infection by Western Blot, EIA assays or viral load.
Exclusion Criteria:
Canada, British Columbia | |
BC St-Paul's Hospital/Immunodeficiency Clinic | |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Canada, Ontario | |
Ottawa Health Research Institute/Immunodeficiency Clinic | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Canada, Quebec | |
Montreal Chest Institute/Immunodeficiency Clinic | |
Montreal, Quebec, Canada, H2X 2P4 | |
CHUL Ste-Foy | |
Ste-Foy, Quebec, Canada, G1V 4G2 | |
Quartier Latin Medical Clinic | |
Montreal, Quebec, Canada, H2L 5B1 | |
Actuel Medical Clinic | |
Montreal, Quebec, Canada, H2L 4P9 |
Principal Investigator: | Jean-Pierre Routy, MD | Royal-Victoria Hospital/McGill University Health Centre |
Responsible Party: | McGill University Health Center ( Jean-Pierre Routy, MD; Principal Investigator ) |
Study ID Numbers: | BMB#05-018 (CTN-205) |
Study First Received: | February 8, 2006 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00289952 History of Changes |
Health Authority: | Canada: Health Canada |
HIV infections Histone deacetylase Inhibitor HIV Reservoirs |
Peripheral Blood Mononuclear Cells Valproic Acid Treatment Experienced |
Neurotransmitter Agents Sexually Transmitted Diseases, Viral Tranquilizing Agents Acquired Immunodeficiency Syndrome Psychotropic Drugs Central Nervous System Depressants Antimanic Agents |
Valproic Acid Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Retroviridae Infections Anticonvulsants |
Neurotransmitter Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Infection Valproic Acid Therapeutic Uses Retroviridae Infections RNA Virus Infections Tranquilizing Agents Immune System Diseases |
Acquired Immunodeficiency Syndrome Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections GABA Agents Central Nervous System Agents Anticonvulsants |