Valproic Acid and Its Effects on HIV Latent Reservoirs
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, Histone deacetylase Inhibitor, HIV Reservoirs, Peripheral Blood Mononuclear Cells, Valproic Acid, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: Documented HIV seropositive infection by Western Blot, EIA assays or viral load. Aged 18 years old or older. Viral load <50 copies/ml for at least the previous 12 months. Circulating CD4+ cell count ³ 200 cells/ml. Taking HAART. Vital signs, physical examination and laboratory results do not exhibit evidence of diseases such as advanced cirrhosis and advanced liver disease (ALT or AST > 5 x upper limit of normal value). Karnofsky performance status 80%. Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with VPA. Willing and able to give informed consent. All participants will agree to abstinence or to used effective methods of contraception while on the study. Exclusion Criteria: Pregnant or breast-feeding women. Psychiatric or cognitive disturbance or illness that could preclude compliance with the study. Current use or use within four weeks prior to the baseline visit, of cytotoxic agents, systemic corticosteroids or any immunomodulatory agents such as intravenous immunoglobulin, or hydroxyurea. HIV vaccine within six months of screening visit Allergic reaction to VPA. Active intravenous drug users. History of bleeding disorders. Unstable or treated hypertension. Past-history of pancreatitis or chronic liver disease (ALT or AST > 5 x upper limit of normal value). However subject co-infected with hepatitis B or C can participate if ALT or AST is < 5 x upper limit of normal value. Renal failure (creatinine > 2 x upper limit of normal value). Ammonemia (> 2x upper limit of normal value). Taking Zidovudine (AZT), or combination of drugs containing AZT like Combivir or Trizivir. However this subject will be asked to switch to another NRTI,at least two weeks prior to Valproic Acid initiation, to become eligible. Taking on daily basis: phenytoin, carbamazepine, phenobarbital, warfarin or aspirin. Subject has any of the following abnormal laboratory results Hemoglobin < 100 g/L. Absolute neutrophil count < 0.75 x 10 9 cells/L. Platelet count < 50 x 10 9 cells/L. Subject suffering from urea cycle disorders.
Sites / Locations
- BC St-Paul's Hospital/Immunodeficiency Clinic
- Ottawa Health Research Institute/Immunodeficiency Clinic
- Actuel Medical Clinic
- Quartier Latin Medical Clinic
- Montreal Chest Institute/Immunodeficiency Clinic
- CHUL Ste-Foy
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
Group 2
HAART + valproic acid for 16 weeks followed by HAART alone for 32 weeks.
HAART alone for 16 weeks followed by HAART + valproic acid for 32 weeks.