Pravastatin and Protease Inhibitors in HIV-Infected Patients
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|ClinicalTrials.gov Identifier: NCT00221754|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Hypercholesterolemia||Drug: Pravastatin (drug)||Phase 2|
Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels.
Design. randomized double-blind, multicentric.
Intervention. Pravastatin versus placebo for 12 weeks.
Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for >= 3 months, plasma HIV-RNA level of < 50 copies/mL for >= 3 months before randomization, total cholesterol >= 5.5 mmol/L with LDL-cholesterol >= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent
Outcomes. HIV RNA at 12 weeks
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy|
|Study Start Date :||March 2003|
|Study Completion Date :||March 2004|
- HIV RNA [ Time Frame: at 12 weeks ]
- Lipid biological markers
- Plasma level of protease inhibitors
- CD4 count at 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221754
|Hôpital Saint André, Service de médecine interne et maladies infectieuses|
|Bordeaux, France, 33000|
|Principal Investigator:||Fabrice BONNET, Dr||University Hospital Bordeaux, France|
|Study Chair:||Geneviève CHENE, Pr||University Hospital, Bordeaux France|