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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, France, 75877
Local Institution
Paris, France, 75651
Local Institution
Paris Cedex 15, France, 75908
Local Institution
Paris Cedex 20, France, 75970
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Yacia Bennai, MD 00 33 1 58 83 63 84
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00312754     History of Changes
Other Study ID Numbers: AI424-108, Amazone
Study First Received: November 14, 2005
Last Updated: February 3, 2010
Health Authority: France:Federal Institution

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013