Study Stopped
insufficient enrollment
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
2 other identifiers
interventional
70
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Jun 2005
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedSeptember 19, 2016
September 1, 2016
1.8 years
November 14, 2005
September 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Secondary Outcomes (3)
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.-
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- Treated Metabolic Syndrom
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Local Institution
Bobigny, 93009, France
Local Institution
Le Kremlin-Bicêtre, 94270, France
Local Institution
Paris, 75651, France
Local Institution
Paris, 75877, France
Local Institution
Paris, 75908, France
Local Institution
Paris, 75970, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yacia Bennai, MD
00 33 1 58 83 63 84
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 14, 2005
First Posted
April 11, 2006
Study Start
June 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
September 19, 2016
Record last verified: 2016-09