Safety Study of Elvucitabine in HIV-1 Subjects | NCT00405249

Studies
Safety Study of Elvucitabine in HIV-1 Subjects

NCT00405249

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Feb 4, 2009Estimated

Enrollment

5Estimated

Phase

Phase 2

Conditions

HIV Infections

Interventions

elvucitabine

Countries

United States

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Nov 29, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Nov 30, 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

Feb 3, 2009

Last Update Posted Date

Feb 4, 2009Estimated

Description Module

Brief Summary

The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

Detailed Description

This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.

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

5Estimated

Name	Type	Description	Arm Group Labels	Other Names
elvucitabine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV infected, clinically stable, adults
HIVRNA 5000 -150,000, CD4 100
Genotypically documented M184V variant
Receiving stable ART.

Exclusion Criteria:

Hep B
HIV-1 genotype for 4 protease inhibitors
HIV-1 genotype positive for 2 NNRTI mutations
Previous therapy with system myelosuppressive potential within 3 months of study start
Use of Epogen or Neupogen
History of cirrhosis
Alcohol or drug dependence
Inability to tolerate oral medication
Women who are pregnant or breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathleen Squires, MD	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

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
C099405	dexelvucitabine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided