A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
Phase 4
Terminated
- Conditions
- HIV Infections
- Registration Number
- NCT00312754
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Documented Metabolic Syndrome by at least 3 of the following parameters:
- Abdominal obesity, assessed by waist circumference (for men >103 cm, for women >88 cm).
- Triglycerides > 150 mg/dl.
- HDL cholestrol (for men <40 mg/dl, for women <50 mg/dl).
- Blood pressure > or equal to 130/85 mm Hg.
- Fasting serum glucose > or equal to 110 mg/dl.
- HIV RNA < 50 copies/mL.
- IP within 3 months prior to selection.
Exclusion Criteria
-Treated Metabolic Syndrom
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
- Secondary Outcome Measures
Name Time Method The change in FMD from ref. value after a 12-wk ATV/RTV treatment period. The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period. The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-
Trial Locations
- Locations (1)
Local Institution
🇫🇷Paris, France