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

This study has been terminated.
(insufficient enrollment)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00312754
First received: November 14, 2005
Last updated: February 3, 2010
Last verified: June 2008

November 14, 2005
February 3, 2010
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Atazanavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00312754
AI424-108, Amazone
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Yacia Bennai, MD 00 33 1 58 83 63 84
Bristol-Myers Squibb
June 2008

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