Status:
COMPLETED
Valproic Acid and Its Effects on HIV Latent Reservoirs
Lead Sponsor:
Jean-Pierre Routy
Collaborating Sponsors:
Canadian Foundation for AIDS Research (CANFAR)
CIHR Canadian HIV Trials Network
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 infe...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00289952
Start Date
June 1 2006
End Date
December 1 2012
Last Update
March 15 2023
Active Locations (6)
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1
BC St-Paul's Hospital/Immunodeficiency Clinic
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Ottawa Health Research Institute/Immunodeficiency Clinic
Ottawa, Ontario, Canada, K1H 8L6
3
Actuel Medical Clinic
Montreal, Quebec, Canada, H2L 4P9
4
Quartier Latin Medical Clinic
Montreal, Quebec, Canada, H2L 5B1