Pravastatin and Protease Inhibitors in HIV-Infected Patients
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To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
Condition | Intervention | Phase |
---|---|---|
HIV Infection Hypercholesterolemia |
Drug: Pravastatin (drug) |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy |
- HIV RNA [ Time Frame: at 12 weeks ]
- Lipid biological markers
- Plasma level of protease inhibitors
- CD4 count at 12 weeks
- Safety
Enrollment: | 21 |
Study Start Date: | March 2003 |
Study Completion Date: | March 2004 |
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
![](https://webarchive.library.unt.edu/web/20130305102412im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
- Age above 18 years
- 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,
- signed informed consent
Exclusion Criteria:
- Current AIDS event or infectious disease
- Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
- Psychiatric conditions
- Biological elevated muscular enzymes
- Chronic alcohol consumption
- Pregnancy
![](https://webarchive.library.unt.edu/web/20130305102412im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
France | |
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 |
![](https://webarchive.library.unt.edu/web/20130305102412im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00221754 History of Changes |
Other Study ID Numbers: | 9268-02, 2001-026 |
Study First Received: | September 13, 2005 |
Last Updated: | June 12, 2007 |
Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Bordeaux:
HIV, protease inhibitors pravastatin Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hypercholesterolemia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Protease Inhibitors Pravastatin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2013