A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
( insufficient enrollment )
Information provided by (Responsible Party)
First received: November 14, 2005
Last updated: September 16, 2016
Last Verified: September 2016
History of Changes
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.
Drug : Atazanavir
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.
- 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.-
|Study Start Date:||June 2005|
|Study Completion Date:||April 2007|
|Estimated Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Treated Metabolic Syndrom
Contacts and LocationsChoosing 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 Show More
|Bobigny, France, 93009|
|Le Kremlin Bicetre, France, 94270|
|Paris Cedex 15, France, 75908|
|Paris Cedex 20, France, 75970|
|Paris, France, 75651|
|Paris, France, 75877|
Sponsors and CollaboratorsBristol-Myers Squibb
|Study Director:||Yacia Bennai, MD||00 33 1 58 83 63 84|
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|
|Study First Received:||November 14, 2005|
|Last Updated:||September 16, 2016|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.