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Pravastatin and Protease Inhibitors in HIV-Infected Patients

Primary Purpose

HIV Infection, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Pravastatin (drug)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV,, protease inhibitors, pravastatin, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Saint André, Service de médecine interne et maladies infectieuses

Outcomes

Primary Outcome Measures

HIV RNA

Secondary Outcome Measures

Lipid biological markers
Plasma level of protease inhibitors
CD4 count at 12 weeks
Safety

Full Information

First Posted
September 13, 2005
Last Updated
June 12, 2007
Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00221754
Brief Title
Pravastatin and Protease Inhibitors in HIV-Infected Patients
Official Title
Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Hypercholesterolemia
Keywords
HIV,, protease inhibitors, pravastatin, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pravastatin (drug)
Primary Outcome Measure Information:
Title
HIV RNA
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
Lipid biological markers
Title
Plasma level of protease inhibitors
Title
CD4 count at 12 weeks
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice BONNET, Dr
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geneviève CHENE, Pr
Organizational Affiliation
University Hospital, Bordeaux France
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Saint André, Service de médecine interne et maladies infectieuses
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Pravastatin and Protease Inhibitors in HIV-Infected Patients

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