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

Last updated: June 23, 2005
Sponsor: Glaxo Wellcome
Overall Status: Trial Status Unknown

Phase

3

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT00004981
308A
ESS40005
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 230
Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • AIDS Healthcare Foundation

    Los Angeles, California 900276069
    United States

    Site Not Available

  • Tower Infectious Disease Med Ctr

    Los Angeles, California 90048
    United States

    Site Not Available

  • Robert Scott MD

    Oakland, California 94609
    United States

    Site Not Available

  • St Lukes Medical Group

    San Diego, California 92101
    United States

    Site Not Available

  • Georgetown Univ Med Ctr

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Whitman Walker Clinic

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Specialty Med Care Ctrs of South Florida Inc

    Miami, Florida 33142
    United States

    Site Not Available

  • Univ of Miami School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Saint Josephs Comprehensive Research Institute

    Tampa, Florida 33607
    United States

    Site Not Available

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois 60612
    United States

    Site Not Available

  • New England Med Ctr

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Research Med Ctr

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Addiction Research and Treatment Corp

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Saint Vincent's Hosp and Med Ctr

    New York, New York 10011
    United States

    Site Not Available

  • St Luke Roosevelt Hosp

    New York, New York 10011
    United States

    Site Not Available

  • Lehigh Valley Hosp

    Allentown, Pennsylvania 18105
    United States

    Site Not Available

  • Hahnemann Univ Hosp

    Philadelphia, Pennsylvania 191021192
    United States

    Site Not Available

  • Anderson Clinical Research

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Burnside Clinic

    Columbia, South Carolina 29206
    United States

    Site Not Available

  • Univ of Tennessee

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Nashville Health Management Foundation / Vanderbilt Univ

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Nicholas Bellos

    Dallas, Texas 75246
    United States

    Site Not Available

  • Univ of Texas Med Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • Therapeutic Concepts

    Houston, Texas 77004
    United States

    Site Not Available

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