A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
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.
|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|
- 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|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
|Bobigny, France, 93009|
|Le Kremlin Bicetre, France, 94270|
|Paris, France, 75877|
|Paris, France, 75651|
|Paris Cedex 15, France, 75908|
|Paris Cedex 20, France, 75970|
|Study Director:||Yacia Bennai, MD||00 33 1 58 83 63 84|