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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
  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:


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

ClinicalTrials.gov processed this record on November 20, 2014