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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atazanavir

Intervention Type DRUG

Eligibility Criteria

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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.