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| ID | Type | Description | Link |
|---|---|---|---|
| 2001-026 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pravastatin | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin (drug) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HIV RNA | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid biological markers | ||
| Plasma level of protease inhibitors | ||
| CD4 count at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice BONNET, Dr | University Hospital Bordeaux, France | Principal Investigator |
| Geneviève CHENE, Pr | University Hospital, Bordeaux France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint André, Service de médecine interne et maladies infectieuses | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17434849 | Result | Bonnet F, Aurillac-Lavignolle V, Breilh D, Thiebaut R, Peuchant E, Bernard N, Lacoste D, Dabis F, Beylot J, Chene G, Morlat P; GECSA. Pravastatin in HIV-infected patients treated with protease inhibitors: a placebo-controlled randomized study. HIV Clin Trials. 2007 Jan-Feb;8(1):53-60. doi: 10.1310/hct0801-53. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Safety |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |