Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

June 23, 2005 updated by: Glaxo Wellcome

A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.

Study Type

Interventional

Enrollment

230

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
    • California
      • Los Angeles, California, United States, 900276069
        • AIDS Healthcare Foundation
      • Los Angeles, California, United States, 90048
        • Tower Infectious Disease Med Ctr
      • Oakland, California, United States, 94609
        • Robert Scott MD
      • San Diego, California, United States, 92101
        • St Lukes Medical Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Miami, Florida, United States, 33142
        • Specialty Med Care Ctrs of South Florida Inc
      • Tampa, Florida, United States, 33607
        • Saint Josephs Comprehensive Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Med Ctr
    • New York
      • Brooklyn, New York, United States, 11201
        • Addiction Research and Treatment Corp
      • New York, New York, United States, 10011
        • St Luke Roosevelt Hosp
      • New York, New York, United States, 10011
        • Saint Vincent's Hosp and Med Ctr
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Hosp
      • Philadelphia, Pennsylvania, United States, 191021192
        • Hahnemann Univ Hosp
      • Pittsburgh, Pennsylvania, United States, 15213
        • Anderson Clinical Research
    • South Carolina
      • Columbia, South Carolina, United States, 29206
        • Burnside Clinic
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Health Management Foundation / Vanderbilt Univ
    • Texas
      • Dallas, Texas, United States, 75246
        • Nicholas Bellos
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts

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

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
  • Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
  • Have CD4+ cell count greater than 200 cells/mm3.
  • Agree to use effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have been diagnosed with AIDS.
  • Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
  • Have hepatitis.
  • Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
  • Are allergic to any of the study drugs.
  • Abuse alcohol or drugs.
  • Will not be available for the entire 24-week study period.
  • Are pregnant or breast-feeding.
  • Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
  • Are enrolled in another experimental drug study.

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

Collaborators and Investigators

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

Sponsor

Glaxo Wellcome

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 Registration Dates

First Submitted

March 13, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308A
  • ESS40005

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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