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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 4

Conditions

HIV Infections

Treatments

Drug: Atazanavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00312754

AI424-108

Amazone

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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