Clinical Trial: A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

This study is no longer recruiting patients.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

Purpose

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.

Condition Treatment or Intervention
HIV Infections
 Drug: Stavudine
 Drug: Zidovudine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study

Official Title: A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients with HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

  • AZT. Patients must have:
  • Documented HIV infection as determined by a positive ELISA and/or Western blot.
  • Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.
  • Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms and conditions are excluded:

  • Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.
  • Need for chronic systemic therapy at time of enrollment.
  • Intractable diarrhea.
  • Signs or symptoms of bilateral peripheral neuropathy at time of screening.
  • Demonstrated intolerance to zidovudine therapy.
  • Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements. Concurrent Medication: Excluded:
  • Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction. Patients with the following prior conditions are excluded:
  • Prior history of bilateral peripheral neuropathy.
  • Demonstrated intolerance to zidovudine therapy. Prior Medication: Excluded:
  • Prior d4T, ddI, or ddC.
  • Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).
  • Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.
  • Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.

Required:

  • At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.

Location Information


Arizona
      Univ of Arizona / Health Science Ctr, Tucson,  Arizona,  85724,  United States

California
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States

      Combat Group, Los Angeles,  California,  90028,  United States

      Cedars Sinai Med Ctr, Los Angeles,  California,  90048,  United States

      Children's Hosp of Los Angeles, Los Angeles,  California,  90027,  United States

      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States

      UCD Med Ctr / AIDS and Related Disorders Clinic, Sacramento,  California,  95817,  United States

      Children's Hosp of San Francisco, San Francisco,  California,  94118,  United States

      Harbor UCLA Med Ctr, Torrance,  California,  90502,  United States

Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States

District of Columbia
      Whitman - Walker Clinic, Washington,  District of Columbia,  20009,  United States

      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States

Florida
      Univ of Miami, Miami,  Florida,  331016960,  United States

      Community Research Initiative of South Florida, Coral Gables,  Florida,  33146,  United States

      TheraFirst Med Ctrs Inc, Fort Lauderdale,  Florida,  33308,  United States

      Infectious Disease Research Institute Inc, Tampa,  Florida,  33614,  United States

Georgia
      Dr Steven Marlowe, Atlanta,  Georgia,  30327,  United States

Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States

      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States

Indiana
      Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States

Kansas
      Univ of Kansas School of Medicine / Univ Hosp, Kansas City,  Kansas,  661607354,  United States

      Univ of Kansas School of Medicine, Wichita,  Kansas,  672143124,  United States

Maryland
      Chase Braxton Health Service, Baltimore,  Maryland,  21201,  United States

Massachusetts
      New England Deaconess Hosp, Boston,  Massachusetts,  02215,  United States

Nebraska
      Univ of Nebraska Med Ctr / HIV Clinic, Omaha,  Nebraska,  681985130,  United States

New Mexico
      Univ of New Mexico School of Medicine, Albuquerque,  New Mexico,  87131,  United States

New York
      Bronx Veterans Affairs Med Ctr, Bronx,  New York,  10468,  United States

      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10019,  United States

      Beth Israel Med Ctr, New York,  New York,  10003,  United States

      Cornell Univ Med College, New York,  New York,  10021,  United States

      SUNY / Health Sciences Ctr at Stony Brook, Stony Brook,  New York,  117948153,  United States

      Mount Sinai Med Ctr, New York,  New York,  10029,  United States

North Carolina
      Nalle Clinic, Charlotte,  North Carolina,  28207,  United States

      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States

Pennsylvania
      Univ of Pennsylvania / HIV Clinic, Philadelphia,  Pennsylvania,  19104,  United States

      Montefiore Hosp, Pittsburgh,  Pennsylvania,  15213,  United States

      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States

South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  29425,  United States

Texas
      Houston Clinical Research Network, Houston,  Texas,  77006,  United States

      Dr Edward Stool, Houston,  Texas,  77004,  United States

      Univ TX San Antonio Health Science Ctr, San Antonio,  Texas,  782847881,  United States

      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States

Utah
      Univ of Utah School of Medicine, Salt Lake City,  Utah,  84132,  United States

Wisconsin
      Milwaukee County Med Complex, Milwaukee,  Wisconsin,  53226,  United States

Puerto Rico
      UPR School of Medicine / San Juan Veterans Adm Med Ctr, San Juan,  009275800,  Puerto Rico

More Information

Publications

Spruance SL, Pavia AT, Mellors JW, Murphy R, Gathe J Jr, Stool E, Jemsek JG, Dellamonica P, Cross A, Dunkle L. Clinical efficacy of monotherapy with stavudine compared with zidovudine in HIV-infected, zidovudine-experienced patients. A randomized, double-blind, controlled trial. Bristol-Myers Squibb Stavudine/019 Study Group. Ann Intern Med. 1997 Mar 1;126(5):355-63.

Study ID Numbers:  116A; AI455-019
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002307
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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