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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00221754 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pravastatin and Protease Inhibitors in HIV-Infected Patients
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Scientific title:
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Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00221754 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Geneviève CHENE, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux France |
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Name:
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Fabrice BONNET, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux, France |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypercholesterolemia
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HIV Infection
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Intervention(s)
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Drug: Pravastatin (drug)
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Primary Outcome(s)
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HIV RNA
[Time Frame: at 12 weeks]
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Secondary Outcome(s)
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Lipid biological markers
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CD4 count at 12 weeks
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Plasma level of protease inhibitors
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Safety
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Secondary ID(s)
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2001-026
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9268-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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