Pravastatin and Protease Inhibitors in HIV-Infected Patients

This study has been completed.

Sponsor:

Collaborator:

Ministry of Health, France

Information provided by:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT00221754

First received: September 13, 2005

Last updated: June 12, 2007

Last verified: June 2007

History of Changes

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Proteinase inhibitor Pravastatin Pravastatin sodium

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

HIV RNA [ Time Frame: at 12 weeks ]

Secondary Outcome Measures:

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

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221754

Locations


France
Hôpital Saint André, Service de médecine interne et maladies infectieuses
Bordeaux, France, 33000

Sponsors and Collaborators

University Hospital, Bordeaux

Ministry of Health, France

Investigators


Principal Investigator:	Fabrice BONNET, Dr	University Hospital Bordeaux, France
Study Chair:	Geneviève CHENE, Pr	University Hospital, Bordeaux France

More Information


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 Hypercholesterolemia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases	Protease Inhibitors HIV Protease Inhibitors Pravastatin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016

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