Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Stavudine (Drug); Didanosine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Kline M, Study Chair
Van Dyke R, Study Chair
Summary
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.
Clinical Details
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
Study design: Treatment, Double-Blind, Safety Study
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
Minimum age: 6 Months.
Maximum age: 10 Years.
Gender(s): Both.
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.
Locations and Contacts
San Juan City Hosp, San Juan 009367344, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan 009365067, Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon 00956, Puerto Rico
Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California 905022004, United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr, Los Angeles, California 900593019, United States
Long Beach Memorial (Pediatric), Long Beach, California 90801, United States
Children's Hosp of Denver, Denver, Colorado 802181088, United States
Univ of Connecticut / Farmington, Farmington, Connecticut 06032, United States
Howard Univ Hosp, Washington, District of Columbia 20060, United States
Children's Hosp of Washington DC, Washington, District of Columbia 200102916, United States
Univ of Miami (Pediatric), Miami, Florida 33161, United States
Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, United States
Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland 21201, United States
Children's Hosp of Boston, Boston, Massachusetts 021155724, United States
Children's Hosp of Michigan, Detroit, Michigan 48201, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey 089030019, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark, New Jersey 071072198, United States
King's County Hosp Ctr / Pediatrics, Brooklyn, New York 11203, United States
Harlem Hosp Ctr, New York, New York 10037, United States
SUNY - Brooklyn, Brooklyn, New York 11203, United States
North Shore Univ Hosp, Great Neck, New York 11021, United States
Schneider Children's Hosp, New Hyde Park, New York 11040, United States
Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Mount Sinai Med Ctr / Pediatrics, New York, New York 10029, United States
Metropolitan Hosp Ctr, New York, New York 10029, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10457, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania 191341095, United States
Med Univ of South Carolina, Charleston, South Carolina 294253312, United States
Children's Med Ctr of Dallas, Dallas, Texas 75235, United States
Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States
Additional Information
Click here for more information about Didanosine Click here for more information about Stavudine
Related publications: Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, Diaz C, Yogev R, McKinney RE Jr, Abrams EJ, Mofenson LM. Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team. Pediatrics. 1999 May;103(5):e62. Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.
Last updated: June 23, 2005
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