Clinical Trial: A Study of Zidovudine (AZT) Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Patients with Little or No Previous Treatment

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: AIDS Clinical Trials Information Service

Purpose

To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Saquinavir
 Drug: Zidovudine
 Drug: Zalcitabine
Phase III

MedlinePlus related topics:  AIDS

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

Official Title: A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients with CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3

Further Study Details: 

Expected Total Enrollment:  3000

Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

  • Erythropoietin and G-CSF. Concurrent Treatment: Allowed:
  • Local skin radiotherapy. Patients must have:
  • HIV infection.
  • CD4 count 50 - 350 cells/mm3.
  • No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
  • No acute serious opportunistic infections requiring immediate treatment.
  • No unexplained fever persisting for 14 days within 90 days prior to study entry.
  • No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry.
  • No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy.
  • Life expectancy of at least 80 weeks.

Exclusion Criteria

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

  • Malabsorption.
  • Severe chronic diarrhea.
  • Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).
  • Any grade 3 or worse toxicity.
  • Inability to comply with study requirements.

Concurrent Medication: Excluded:

  • Other investigational agents.
  • Antineoplastic agents.
  • Biologic response modifiers (including interferons).
  • Foscarnet.
  • Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded:
  • Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded:
  • Acute therapy for opportunistic infection within 14 days prior to study entry.
  • Prior HIV proteinase inhibitor.

Location Information


Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85016,  United States

California
      UCD Med Ctr, Sacramento,  California,  95817,  United States

      Sunnyvale Med Clinic, Sunnyvale,  California,  94086,  United States

      Pacific Oaks Med Group, Sherman Oaks,  California,  91403,  United States

      Davies Med Ctr, San Francisco,  California,  94114,  United States

      Mount Zion Med Ctr / UCSF, San Francisco,  California,  94115,  United States

District of Columbia
      Howard Univ, Washington,  District of Columbia,  20060,  United States

      Novum Inc, Washington,  District of Columbia,  20037,  United States

Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States

      Miami Veterans Administration Med Ctr, Miami,  Florida,  33125,  United States

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

      Cook County Hosp, Chicago,  Illinois,  60612,  United States

Louisiana
      Tulane Univ Med School, New Orleans,  Louisiana,  701122699,  United States

Massachusetts
      Massachusetts Gen Hosp, Boston,  Massachusetts,  02114,  United States

Nevada
      HIV Wellness Ctr / Univ Med Ctr, Las Vegas,  Nevada,  89102,  United States

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

      Harkness Pavilion, New York,  New York,  10032,  United States

Ohio
      Univ Hosp of Cleveland / Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States

Oklahoma
      Univ of Oklahoma Health Science / Pharmacy Practice, Oklahoma City,  Oklahoma,  73117,  United States

Pennsylvania
      Novum Inc, Pittsburgh,  Pennsylvania,  152063817,  United States

Texas
      N Texas Ctr for AIDS & Clin Rsch, Dallas,  Texas,  75219,  United States

      Univ TX Galveston Med Branch, Galveston,  Texas,  775550882,  United States

      Thomas Street Clinic / Baylor College of Medicine, Houston,  Texas,  77009,  United States

      Respiratory Associates, Corpus Christi,  Texas,  78404,  United States

Washington
      Univ of Washington, Seattle,  Washington,  981224379,  United States

Puerto Rico
      San Juan Veterans Administration Med Ctr, San Juan,  009275800,  Puerto Rico

More Information

Publications

Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60

Study ID Numbers:  229B; SV 14604C; SV 14604A
Record last reviewed:  September 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002334
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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