A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate

Criteria

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