Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

April 6, 2015 updated by: ViiV Healthcare

A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 4

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
    • California
      • Los Angeles, California, United States, 90027
        • GSK Investigational Site
      • San Rafael, California, United States, 94903
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33145
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32206
        • GSK Investigational Site
      • Lake Worth, Florida, United States, 33463
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Miami Beach, Florida, United States, 33139
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32303
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60657
        • GSK Investigational Site
      • Maywood, Illinois, United States, 60153
        • GSK Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • GSK Investigational Site
    • Michigan
      • Berkeley, Michigan, United States, 48072
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site
      • New York, New York, United States, 10014
        • GSK Investigational Site
      • Valhalla, New York, United States, 10595
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76015
        • GSK Investigational Site
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75216
        • GSK Investigational Site
      • Dallas, Texas, United States, 75208
        • GSK Investigational Site
      • Houston, Texas, United States, 77004
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • 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:

  • Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
  • Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
  • Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
  • A CD4+ lymphocyte count less than or equal to 100.

Exclusion Criteria:

  • Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
  • Have not had an AIDS defining illness within 30 days of screen.
  • Pregnant or breast-feeding.
  • Specified viral genotypes upon screening.
  • And other inclusion or exclusion criteria to be evaluated by the physician.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

ViiV Healthcare

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

March 1, 2002

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

May 31, 2002

First Submitted That Met QC Criteria

May 31, 2002

First Posted (Estimate)

June 3, 2002

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESS 30005

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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