NCT00221754

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

September 13, 2005

Last Update Submit

June 12, 2007

Conditions

HIV InfectionHypercholesterolemia

Keywords

HIV,protease inhibitorspravastatinTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • HIV RNA

    at 12 weeks

Secondary Outcomes (4)

  • Lipid biological markers

  • Plasma level of protease inhibitors

  • CD4 count at 12 weeks

  • Safety

Interventions

Pravastatin (drug)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current AIDS event or infectious disease
  • Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
  • Psychiatric conditions
  • Biological elevated muscular enzymes
  • Chronic alcohol consumption
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint André, Service de médecine interne et maladies infectieuses

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

HIV InfectionsHypercholesterolemia

Interventions

PravastatinPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Fabrice BONNET, Dr

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Geneviève CHENE, Pr

    University Hospital, Bordeaux France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 1, 2003

Study Completion

March 1, 2004

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

FR(1)