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

A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312754

Enrollment

Registered

2006-04-11

Start date

2005-06-30

Completion date

2007-04-30

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGAtazanavir

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.-	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026