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Clinical Trials

MainTitle

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

This study has been terminated
( insufficient enrollment )

Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT00312754

First received: November 14, 2005
Last updated: September 16, 2016
Last Verified: September 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Atazanavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures

  • To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Secondary Outcome Measures:
  • 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.-

Estimated Enrollment: 70
Study Start Date: June 2005
Study Completion Date: April 2007
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312754

Locations

France
Local Institution
Bobigny, France, 93009
Local Institution
Le Kremlin Bicetre, France, 94270
Local Institution
Paris Cedex 15, France, 75908
Local Institution
Paris Cedex 20, France, 75970
Local Institution
Paris, France, 75651
Local Institution
Paris, France, 75877

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Yacia Bennai, MD 00 33 1 58 83 63 84
More Information

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT00312754   History of Changes  
Other Study ID Numbers: AI424-108  
  Amazone  
Study First Received: November 14, 2005  
Last Updated: September 16, 2016  

Additional relevant MeSH terms:
HIV Infections
Atazanavir Sulfate

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.