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

Phase 4TerminatedNCT00312754

Bristol-Myers Squibb70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

AtazanavirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Local Institution

Bobigny, France

Local Institution

Le Kremlin-Bicêtre, France

Local Institution

Paris, France

Local Institution

Paris, France

Local Institution

Outcomes

Primary Outcomes

To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.

Secondary Outcomes

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.-

Data from ClinicalTrials.gov

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