Pravastatin and Protease Inhibitors in HIV-infected Patients

Pravastatin in HIV-infected Patients Treated With Highly Active Antiretroviral Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00221754

Enrollment

Registered

2005-09-22

Start date

2003-03-01

Completion date

2004-03-01

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Hypercholesterolemia

Keywords

HIV,, protease inhibitors, pravastatin, Treatment Experienced

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

Interventions

DRUGPravastatin (drug)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
HIV RNA	at 12 weeks

Secondary

Measure	Time frame
Lipid biological markers	—
Plasma level of protease inhibitors	—
CD4 count at 12 weeks	—
Safety	—

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFabrice BONNET, Dr

University Hospital Bordeaux, France

STUDY_CHAIRGeneviève CHENE, Pr

University Hospital, Bordeaux France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026