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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000851
First received: November 2, 1999
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Stavudine
Drug: Didanosine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 198
Study Completion Date: October 1998
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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000851

  Hide Study Locations
Locations
United States, California
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90502
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
United States, Connecticut
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06032
Connecticut Children's Med. Ctr.
Hartford, Connecticut, United States
United States, District of Columbia
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
Children's National Med. Ctr., ACTU
Washington, District of Columbia, United States, 20010
United States, Florida
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Cook County Hosp.
Chicago, Illinois, United States, 60612
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
United States, Louisiana
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
United States, New Jersey
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States, 08903
NJ Med. School CRS
Newark, New Jersey, United States
United States, New York
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Columbia IMPAACT CRS
New York, New York, United States, 10032
Metropolitan Hosp. NICHD CRS
New York, New York, United States, 10029
Incarnation Children's Ctr.
New York, New York, United States, 10032
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
United States, North Carolina
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
United States, Pennsylvania
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 29425
United States, Texas
Children's Med. Ctr. Dallas
Dallas, Texas, United States, 75235
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Puerto Rico
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamon, Puerto Rico, 00956
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: Kline M
Study Chair: Van Dyke R
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000851     History of Changes
Other Study ID Numbers: ACTG 327, 11300
Study First Received: November 2, 1999
Last Updated: May 1, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Therapy, Combination
Antiviral Agents
Stavudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Stavudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 21, 2014