Pravastatin and Protease Inhibitors in HIV-Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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HIV Infection Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pravastatin (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Fabrice BONNET, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Geneviève CHENE, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux France

Locations

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Hôpital Saint André, Service de médecine interne et maladies infectieuses

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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2001-026

Identifier Type: -

Identifier Source: secondary_id

9268-02