Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine

To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.

In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.

Study Type

Interventional

Enrollment

198

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
      • Torrance, California, United States, 90502
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Colorado
      • Aurora, Colorado, United States
        • Univ. of Colorado Denver NICHD CRS
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
      • Hartford, Connecticut, United States
        • Connecticut Children's Med. Ctr.
    • 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
      • Jacksonville, Florida, United States, 32209
        • Univ. of Florida Jacksonville NICHD CRS
      • Miami, Florida, United States, 33161
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
    • 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
    • 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
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ - Robert Wood Johnson
      • Newark, New Jersey, United States
        • NJ Med. School CRS
    • New York
      • 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, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr.
      • New York, New York, United States, 10029
        • Metropolitan Hosp. NICHD CRS
      • Rochester, New York, United States
        • Strong Memorial Hospital Rochester NY NICHD CRS
      • Stony Brook, New York, United States
        • SUNY Stony Brook NICHD CRS
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • DUMC Ped. CRS
    • Pennsylvania
      • 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
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Med. Ctr. Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS

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

6 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must:

  • Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
  • Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
  • Have parent or legal guardian willing to sign a consent.

Prior Medication: Required:

  • On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Intractable diarrhea or vomiting.
  • Current clinical or laboratory Grade 3 or worse toxicities.

Concurrent Medication:

Excluded:

  • Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
  • Chemotherapy for active malignancy.

Patients with any of the following prior conditions are excluded:

  • Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
  • Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
  • Subjects who have had chemotherapy for active malignancy.

Prior Medication:

Excluded:

  • Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.

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)

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)

October 1, 1998

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 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 327
  • 11300 (Registry Identifier: 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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