A Multiple Ascending Dose Study of BMS-707035 in HIV-1 In... | NCT00397566

Studies
A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects

NCT00397566

Sponsor

Bristol-Myers Squibb

Status

Withdrawn

Last Update Posted

Apr 27, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

HIV Infections

Interventions

HIV Integrase Inhibitor (BMS-707035)

Countries

Not provided

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

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2007

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Nov 8, 2006

First Submission Date that Met QC Criteria

Nov 8, 2006

First Posted Date

Nov 9, 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

Apr 26, 2012

Last Update Posted Date

Apr 27, 2012Estimated

Description Module

Brief Summary

The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
HIV Integrase Inhibitor (BMS-707035)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days.

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability with 10 days of dosing
Effect on QTc intervals
Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1-infected subjects with CD4+ lymphocyte count ≥ 200 cells/mm3 and with plasma HIV-1 RNA ≥ 5000 copies/mL who have not been on antiretroviral (ARV) therapy for ≥ 8 weeks or who are naive to ARV, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. In addition, subjects must have had no prior exposure to the Integrase Inhibitor class of compounds.
Female subjects must not be nursing, pregnant, or of childbearing potential

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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
D019429	Integrase Inhibitors
C000629780	BMS-707035

Ancestor Terms

ID	Term
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided