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Safety Study of Elvucitabine in HIV-1 Subjects

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

elvucitabine

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Treatment Experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Thomas Jefferson University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00405249

First Posted

November 29, 2006

Last Updated

February 3, 2009

Sponsor

Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT00405249

Brief Title

Safety Study of Elvucitabine in HIV-1 Subjects

Official Title

14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Thomas Jefferson University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV-1, Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

elvucitabine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Squires, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Elvucitabine in HIV-1 Subjects

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