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

September 13, 2005
June 12, 2007
March 2003
Not Provided
HIV RNA [ Time Frame: at 12 weeks ]
HIV RNA at 12 weeks
Complete list of historical versions of study NCT00221754 on ClinicalTrials.gov Archive Site
  • Lipid biological markers
  • Plasma level of protease inhibitors
  • CD4 count at 12 weeks
  • Safety
  • - Lipid biological markers
  • - Plasma level of protease inhibitors
  • - CD4 count at 12 weeks
  • - Safety
Not Provided
Not Provided
 
Pravastatin and Protease Inhibitors in HIV-Infected Patients
Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy

To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infection
  • Hypercholesterolemia
Drug: Pravastatin (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221754
9268-02, 2001-026
Yes
Not Provided
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Fabrice BONNET, Dr University Hospital Bordeaux, France
Study Chair: Geneviève CHENE, Pr University Hospital, Bordeaux France
University Hospital, Bordeaux
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP