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
  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:


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
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

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
HIV Protease Inhibitors
Pravastatin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

ClinicalTrials.gov processed this record on July 26, 2014