We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pravastatin and Protease Inhibitors in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221754
First Posted: September 22, 2005
Last Update Posted: June 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
  Purpose
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Condition Intervention Phase
HIV Infection Hypercholesterolemia Drug: Pravastatin (drug) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • HIV RNA [ Time Frame: at 12 weeks ]

Secondary Outcome Measures:
  • Lipid biological markers
  • Plasma level of protease inhibitors
  • CD4 count at 12 weeks
  • Safety

Enrollment: 21
Study Start Date: March 2003
Study Completion Date: March 2004
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221754


Locations
France
Hôpital Saint André, Service de médecine interne et maladies infectieuses
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Fabrice BONNET, Dr University Hospital Bordeaux, France
Study Chair: Geneviève CHENE, Pr University Hospital, Bordeaux France
  More Information

ClinicalTrials.gov Identifier: NCT00221754     History of Changes
Other Study ID Numbers: 9268-02
2001-026
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: June 13, 2007
Last Verified: June 2007

Keywords provided by University Hospital, Bordeaux:
HIV,
protease inhibitors
pravastatin
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Hypercholesterolemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Protease Inhibitors
HIV Protease Inhibitors
Pravastatin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors