A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

October 1, 2010 updated by: GlaxoSmithKline

A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

345

Phase

  • Phase 3

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Los Angeles, California, United States, 90033
        • GSK Investigational Site
      • San Francisco, California, United States, 94115-1931
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • GSK Investigational Site
      • Denver, Colorado, United States, 80205
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80528
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20036
        • GSK Investigational Site
      • Washington, District of Columbia, United States, 20007-2113
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33145
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33901
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32206
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Miami, Florida, United States, 33133
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Tampa, Florida, United States, 33602
        • GSK Investigational Site
      • Vero Beach, Florida, United States, 32960
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30339
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60657
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202 - 5124
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70127-0800
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • GSK Investigational Site
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • GSK Investigational Site
      • Buffalo, New York, United States, 14215
        • GSK Investigational Site
      • New York, New York, United States, 10014
        • GSK Investigational Site
      • New York, New York, United States, 10011
        • GSK Investigational Site
      • Stony Brook, New York, United States, 11794
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0405
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
      • Portland, Oregon, United States, 97219
        • GSK Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19102
        • GSK Investigational Site
      • Reading, Pennsylvania, United States, 19601
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29206-4713
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75208
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • Tyler, Texas, United States, 75708
        • GSK Investigational Site
    • Virginia
      • Hampton, Virginia, United States, 23666
        • GSK Investigational Site
      • Lynchburg, Virginia, United States, 24501
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • GSK Investigational Site

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:

  • Participants must be able to provide informed consent.
  • Have documented HIV-1 infection.
  • Have not received more than 14 days of prior treatment with antiretroviral drugs.
  • Meet laboratory test criteria.
  • Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
  • Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

  • Enrolled in other HIV treatment studies.
  • Pregnant or breastfeeding.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load response at 48 weeks
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

February 4, 2003

First Submitted That Met QC Criteria

February 4, 2003

First Posted (Estimate)

February 5, 2003

Study Record Updates

Last Update Posted (Estimate)

October 4, 2010

Last Update Submitted That Met QC Criteria

October 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESS30009

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.

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