Back to resultsA Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Atazanavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Outcomes
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.-
Full Information
NCT ID
NCT00312754
First Posted
November 14, 2005
Last Updated
September 16, 2016
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00312754
Brief Title
A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
insufficient enrollment
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Primary Outcome Measure Information:
Title
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Secondary Outcome Measure Information:
Title
The change in FMD from ref. value after a 12-wk ATV/RTV treatment period.
Title
The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period.
Title
The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yacia Bennai, MD
Organizational Affiliation
00 33 1 58 83 63 84
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Local Institution
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Local Institution
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Local Institution
City
Paris Cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75877
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
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