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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
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Condition or disease Intervention/treatment Phase
HIV Infection Hypercholesterolemia Drug: Pravastatin (drug) Phase 2

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy
Study Start Date : March 2003
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HIV RNA [ Time Frame: at 12 weeks ]

Secondary Outcome Measures :
  1. Lipid biological markers
  2. Plasma level of protease inhibitors
  3. CD4 count at 12 weeks
  4. Safety

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00221754     History of Changes
Other Study ID Numbers: 9268-02
2001-026
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 13, 2007
Last Verified: June 2007

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