Pravastatin and Protease Inhibitors in HIV-Infected Patients
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ClinicalTrials.gov Identifier: NCT00221754 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: June 13, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection Hypercholesterolemia | Drug: Pravastatin (drug) | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy |
Study Start Date : | March 2003 |
Actual Study Completion Date : | March 2004 |

- HIV RNA [ Time Frame: at 12 weeks ]
- Lipid biological markers
- Plasma level of protease inhibitors
- CD4 count at 12 weeks
- Safety

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
Hôpital Saint André, Service de médecine interne et maladies infectieuses | |
Bordeaux, France, 33000 |
Principal Investigator: | Fabrice BONNET, Dr | University Hospital Bordeaux, France | |
Study Chair: | Geneviève CHENE, Pr | University Hospital, Bordeaux France |
ClinicalTrials.gov Identifier: | NCT00221754 History of Changes |
Other Study ID Numbers: |
9268-02 2001-026 |
First Posted: | September 22, 2005 Key Record Dates |
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 |