A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

June 23, 2005 updated by: Hoffmann-La Roche
To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to one of four treatment arms. ddC is administered at 1 of 2 doses every 8 hours. AZT is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).

Study Type

Interventional

Enrollment

528

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
      • Harbor City, California, United States, 90710
        • Kaiser Foundation Hosp
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Med Ctr
      • San Diego, California, United States, 92101
        • Sharp Rees - Stealy Med Group
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Public Health Dept / Disease Control Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard Univ
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Miami, Florida, United States, 33125
        • Miami Veterans Administration Med Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Intergrated Care Ctr
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Univ of Kansas School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • St Paul Ramsey Med Ctr / HIV Program Office
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington Univ
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of New Mexico School of Medicine
    • New York
      • Bronx, New York, United States, 10468
        • Bronx Veterans Affairs Med Ctr
      • Brooklyn, New York, United States, 11203
        • SUNY / Health Sciences Ctr at Brooklyn
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr
    • Ohio
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences Univ
    • Texas
      • Dallas, Texas, United States, 75219
        • N Texas Ctr for AIDS & Clin Rsch
      • Galveston, Texas, United States, 775550882
        • Univ TX Galveston Med Branch
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Dr Brian Buggy

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 must have:

  • HIV infection.
  • CD4 count 100 - 500 cells/mm3.

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

Hoffmann-La Roche

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

February 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220a
  • NV 14257

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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