Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
NCT ID: NCT00000851
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
1998-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Stavudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
6 Months
10 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Kline M
Role: STUDY_CHAIR
Van Dyke R
Role: STUDY_CHAIR
Locations
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Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States
Connecticut Children's Med. Ctr.
Hartford, Connecticut, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Cook County Hosp.
Chicago, Illinois, United States
Chicago Children's CRS
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
NJ Med. School CRS
Newark, New Jersey, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States
Metropolitan Hosp. NICHD CRS
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States
Children's Med. Ctr. Dallas
Dallas, Texas, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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References
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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. doi: 10.1542/peds.103.5.e62.
Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
Other Identifiers
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11300
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 327
Identifier Type: -
Identifier Source: org_study_id