Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221754
Status:
COMPLETED
Last Update Posted:
2007-06-13
First Post:
2005-09-13
Brief Title:
Pravastatin and Protease Inhibitors in HIV-Infected Patients
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study
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 copiesmL for 3 months before randomization total cholesterol 55 mmolL with LDL-cholesterol 34 mmolL on fasting status after three months of standardized dietary advice written informed consent
Outcomes HIV RNA at 12 weeks
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 copiesmL for 3 months before randomization total cholesterol 55 mmolL with LDL-cholesterol 34 mmolL on fasting status after three months of standardized dietary advice written informed consent
Outcomes HIV RNA at 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2001-026 | None | None | None |