A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00312754
• Other study ID #: AI424-108
• Secondary ID: Amazone
• Status: Terminated
• Phase: Phase 4
• First received: November 14, 2005
• Last updated: September 16, 2016
• Start date: June 2005
• Est. completion date: April 2007

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:Federal Institution
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir

Locations

Country	Name	City	State
France	Local Institution	Bobigny
France	Local Institution	Le Kremlin Bicetre
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris Cedex 15
France	Local Institution	Paris Cedex 20

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Secondary	The change in FMD from ref. value after a 12-wk ATV/RTV treatment period.
Secondary	The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period.
Secondary	The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm