A Phase IV Study of BMS-232632 in HIV+ Patients With Meta... | NCT00312754

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

NCT00312754

Sponsor

Bristol-Myers Squibb

Status

Terminated

Last Update Posted

Sep 19, 2016Estimated

Enrollment

Phase

Phase 4

Conditions

HIV Infections

Interventions

Atazanavir

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Amazone

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient enrollment

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Nov 14, 2005

First Submission Date that Met QC Criteria

Apr 10, 2006

First Posted Date

Apr 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2016

Last Update Posted Date

Sep 19, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Atazanavir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yacia Bennai, MD	00 33 1 58 83 63 84	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Bobigny		93009	France
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069446	Atazanavir Sulfate

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides

Browse Leaves

Not provided

Browse Branches

Not provided