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

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ClinicalTrials.gov Identifier: NCT00312754
Recruitment Status : Terminated (insufficient enrollment)
First Posted : April 11, 2006
Last Update Posted : September 19, 2016
Information provided by:
Bristol-Myers Squibb

November 14, 2005
April 11, 2006
September 19, 2016
June 2005
April 2007   (Final data collection date for primary outcome measure)
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Same as current
Complete list of historical versions of study NCT00312754 on ClinicalTrials.gov Archive Site
  • 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.-
Same as current
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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
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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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Atazanavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2007
April 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Bristol-Myers Squibb
Not Provided
Study Director: Yacia Bennai, MD 00 33 1 58 83 63 84
Bristol-Myers Squibb
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP