- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00221754
Pravastatin and Protease Inhibitors in HIV-Infected Patients
Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33000
- Hôpital Saint André, Service de médecine interne et maladies infectieuses
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV RNA
Time Frame: at 12 weeks
|
at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Lipid biological markers
|
Plasma level of protease inhibitors
|
CD4 count at 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Geneviève CHENE, Pr, University Hospital, Bordeaux France
- Principal Investigator: Fabrice BONNET, Dr, University Hospital Bordeaux, France
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Pravastatin
Other Study ID Numbers
- 9268-02
- 2001-026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Merck Sharp & Dohme LLCCompleted
-
Northwestern UniversityPfizer; Tibotec, IncCompletedHIV Infections | HIV-1 InfectionUnited States
Clinical Trials on Pravastatin (drug)
-
Akros Pharma Inc.CompletedType II HyperlipidemiaNetherlands
-
Complexa, Inc.CompletedAcute Kidney InjuryUnited States
-
Daiichi Sankyo, Inc.CompletedHypercholesterolemiaUnited States
-
Pontificia Universidad Catolica de ChileBristol-Myers SquibbWithdrawn
-
Yonsei UniversityCompleted
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPolycystic Kidney, Autosomal DominantUnited States
-
Arkansas Children's Hospital Research InstituteTerminatedEnd Stage Renal DiseaseUnited States
-
National Center for Research Resources (NCRR)UnknownHeart DiseasesUnited States
-
Bristol-Myers SquibbCompletedActue Coronary Syndromes
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | LipodystrophyUnited States, Puerto Rico