A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients

Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related conditions in HIV-infected patients.

Secondary: To compare the frequency and severity of adverse experiences in the three regimens. To compare the mortality rates in the three regimens. To compare the effects of antiretroviral regimens on CD4+ cell levels.

Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.

Approximately 1200 patients are randomized in a 2:1:1:2 ratio to one of the following four treatment arms: AZT plus ddI, AZT plus ddI placebo, AZT plus ddC placebo, and AZT plus ddC. Average follow-up is 2 years.

Study Type

Interventional

Enrollment

1200

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
      • San Francisco, California, United States, 94110
        • Community Consortium of San Francisco
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver CPCRA / Denver Public Hlth
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Hill Health Corp
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Wilmington Hosp / Med Ctr of Delaware
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr / Regional AIDS Program
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Comprehensive AIDS Alliance of Detroit
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • North Jersey Community Research Initiative
    • New York
      • Brooklyn, New York, United States, 11201
        • Addiction Research and Treatment Corp
      • New York, New York, United States, 10011
        • Clinical Directors Network of Region II
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Richmond AIDS Consortium

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Required:

  • Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma).
  • CD4+ cell count = or < 200/mm3 or = or < 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection.
  • Current PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse.
  • Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy.
  • Stage 2 or worse (moderate) AIDS Dementia Complex.
  • Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy.

Concurrent Medication:

Excluded:

  • Acute therapy for active AIDS-defining opportunistic infection.
  • Systemic chemotherapy for malignancy.
  • Antiretroviral therapy other than that provided by this study.

Patients with the following prior conditions are excluded:

  • History of pancreatitis or peripheral neuropathy of grade 2 or worse.
  • History of intolerance to the study drugs at entry doses and/or frequencies.
  • History of phenylketonuria.

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: L Saravolatz
  • Study Chair: D Winslow

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

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 Major Dates

Study Completion (Actual)

December 1, 1995

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 (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 007
  • 11559 (DAIDS ES Registry Number)

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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