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

June 23, 2005 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

3000

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

  • Puerto Rico
      • San Juan, Puerto Rico, 009275800
        • San Juan Veterans Administration Med Ctr
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Body Positive
    • California
      • Sacramento, California, United States, 95817
        • UCD Med Ctr
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Francisco, California, United States, 94115
        • Mount Zion Med Ctr / UCSF
      • Sherman Oaks, California, United States, 91403
        • Pacific Oaks Med Group
      • Sunnyvale, California, United States, 94086
        • Sunnyvale Med Clinic
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Novum Inc
      • Washington, District of Columbia, United States, 20060
        • Howard Univ
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
      • Miami, Florida, United States, 33125
        • Miami Veterans Administration Med Ctr
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ Med School
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Gen Hosp
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • HIV Wellness Ctr / Univ Med Ctr
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10032
        • Harkness Pavilion
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Univ of Oklahoma Health Science / Pharmacy Practice
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 152063817
        • Novum Inc
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Respiratory Associates
      • Dallas, Texas, United States, 75219
        • N Texas Ctr for AIDS & Clin Rsch
      • Galveston, Texas, United States, 775550882
        • Univ TX Galveston Med Branch
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic / Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 981224379
        • Univ of Washington

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

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.

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
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 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

November 2, 1999

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

September 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229B
  • SV 14604C
  • SV 14604A

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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