- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312754
A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
September 16, 2016 updated by: Bristol-Myers Squibb
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
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 Overview
Study Type
Interventional
Enrollment
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bobigny, France, 93009
- Local Institution
-
Le Kremlin Bicetre, France, 94270
- Local Institution
-
Paris, France, 75877
- Local Institution
-
Paris, France, 75651
- Local Institution
-
Paris Cedex 15, France, 75908
- Local Institution
-
Paris Cedex 20, France, 75970
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.-
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yacia Bennai, MD, 00 33 1 58 83 63 84
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
November 14, 2005
First Submitted That Met QC Criteria
April 10, 2006
First Posted (Estimate)
April 11, 2006
Study Record Updates
Last Update Posted (Estimate)
September 19, 2016
Last Update Submitted That Met QC Criteria
September 16, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Atazanavir Sulfate
Other Study ID Numbers
- AI424-108
- Amazone
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | HIV SeronegativityUnited States, Puerto Rico
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
Clinical Trials on Atazanavir
-
Bristol-Myers SquibbCompleted
-
Asan Medical CenterBristol-Myers SquibbUnknown
-
Radboud University Medical CenterDutch Diabetes Research FoundationCompletedEffects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction (DM2ATV)Type 2 Diabetes Mellitus Related Endothelial DysfunctionNetherlands
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbMerck Sharp & Dohme LLCCompleted
-
Bristol-Myers SquibbCompleted
-
Giovanni Di PerriUniversity of Turin, Italy; University of MilanTerminatedHIV Infection | OsteopeniaItaly
-
University of British ColumbiaCompleted
-
Bristol-Myers SquibbCompletedHuman Immunodeficiency Virus Type 1 (HIV-1)United States