A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

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

A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection

PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children.

SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria.

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.

Study Type

Interventional

Enrollment

180

Phase

  • Phase 2

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
      • Bayamon, Puerto Rico, 00956
        • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
      • San Juan, Puerto Rico, 00936
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Puerto Rico, 00936
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • United States
    • California
      • Long Beach, California, United States, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles, California, United States, 90033
        • Usc La Nichd Crs
      • Los Angeles, California, United States
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Oakland, California, United States, 94609
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • San Diego, California, United States, 92093
        • UCSD Maternal, Child, and Adolescent HIV CRS
      • San Francisco, California, United States, 94143
        • UCSF Pediatric AIDS CRS
      • San Francisco, California, United States, 94110
        • San Francisco Gen. Hosp.
      • Torrance, California, United States, 90502
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
      • New Haven, Connecticut, United States, 06504
        • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Med. Ctr., ACTU
      • Washington, District of Columbia, United States, 20060
        • Howard Univ. Washington DC NICHD CRS
    • Florida
      • Miami, Florida, United States, 33161
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp.
      • Chicago, Illinois, United States, 60614
        • Chicago Children's CRS
      • Chicago, Illinois, United States, 60637
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
      • Chicago, Illinois, United States, 60612
        • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane/LSU Maternal/Child CRS
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Boston, Massachusetts, United States, 02118
        • BMC, Div. of Ped Infectious Diseases
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, United States, 01655
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • New Brunswick, New Jersey, United States
        • UMDNJ - Robert Wood Johnson
      • Paterson, New Jersey, United States
        • St. Joseph's Hosp. & Med. Ctr. of New Jersey
    • New York
      • Albany, New York, United States, 12208
        • Children's Hospital at Albany Medical Center, Dept. of Peds.
      • Bronx, New York, United States, 10457
        • Bronx-Lebanon Hosp. IMPAACT CRS
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • Great Neck, New York, United States, 11021
        • North Shore-Long Island Jewish Health System, Dept. of Peds.
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hosp., Div. of Infectious Diseases
      • New York, New York, United States, 10032
        • Columbia IMPAACT CRS
      • New York, New York, United States, 10016
        • NYU Med. Ctr., Dept. of Medicine
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr.
      • New York, New York, United States, 10029
        • Metropolitan Hosp. NICHD CRS
      • New York, New York, United States
        • Harlem Hosp. Ctr. NY NICHD CRS
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • DUMC Ped. CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hosp. of Philadelphia IMPAACT CRS
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hosp. for Children
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
    • Washington
      • Seattle, Washington, United States, 98105
        • UW School of Medicine - CHRMC

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

3 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Recommended:

  • PCP prophylaxis.

Allowed:

  • Intravenous and/or intramuscular immunoglobulin.
  • Acyclovir (no more than 30 mg/kg/day PO).
  • Ketoconazole (no more than 10 mg/kg/day).
  • Nystatin.
  • Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.
  • Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.
  • Trimethoprim / sulfamethoxazole.
  • Amphotericin B (no more than 1 mg/kg for 5 days/week).
  • Aerosolized ribavirin for bronchiolitis.
  • Hematopoietic agents.
  • Other drugs with little nephro-, hepato-, or cytotoxicity.
  • Nutritional support for HIV wasting syndrome or malnutrition.

Patients must have:

  • HIV infection.
  • Ongoing stable AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.
  • Known allergy or sensitivity to ddC.
  • Cardiomyopathy.

Concurrent Medication:

Excluded:

  • Biologic modifiers other than IVIG, steroids, or hematopoietic agents.
  • Investigational medications unless approved by protocol chair.
  • Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).

Patients with the following prior conditions are excluded:

  • History of intolerance or toxicity to AZT.
  • History of symptomatic pancreatitis.
  • History of peripheral neuropathy or abnormal nerve conduction velocity test.

Prior Medication:

Excluded:

  • Antiretroviral agents other than AZT within 2 weeks of study entry.

Required:

  • Ongoing stable AZT therapy for more than 6 weeks duration.

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: S Pahwa
  • Study Chair: SS Bakshi

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)

April 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

  • ACTG 190
  • 11165 (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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