A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
NCT ID: NCT00000789
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
230 participants
INTERVENTIONAL
1998-07-31
Brief Summary
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SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Detailed Description
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Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Stavudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
Recommended:
* PCP prophylaxis.
Allowed:
* Immunoglobulin.
* Erythropoietin, G-CSF, and GM-CSF.
* Corticosteroids.
* Ethionamide or isoniazid for TB if no alternative is available.
* Pyridoxine (up to 50 mg/day) as vitamin supplement.
Patients must have:
* Symptomatic HIV infection.
* No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG).
* Consent of parent or guardian.
NOTE:
* Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted.
Prior Medication:
Allowed:
* Maternal immunomodulator or antiretroviral therapy (including during pregnancy).
* Antiretroviral therapy prior to 2 months.
* Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG).
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Current grade 3 or worse neuropathy / lower motor neuropathy.
* Other grade 3 or worse clinical or laboratory toxicities.
* Known intolerance to either AZT or d4T.
Concurrent Medication:
Excluded:
* Chemotherapy for active malignancy.
Patients with the following prior conditions are excluded:
* History of grade 3 or worse neuropathy/lower motor neuropathy.
Prior Medication:
Excluded:
* More than 6 weeks of prior antiretroviral or immunomodulator therapy.
* Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.
3 Months
6 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
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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Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Usc La Nichd Crs
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
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
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, 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
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States
Cook County Hosp.
Chicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
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
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
Cooper Univ. Hosp.
Camden, New Jersey, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, 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
NYU Med. Ctr., Dept. of Medicine
New York, 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
Univ. of Rochester ACTG CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States
DUMC Ped. CRS
Durham, North Carolina, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 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
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Children's Med. Ctr. Dallas
Dallas, Texas, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
UW School of Medicine - CHRMC
Seattle, Washington, 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, Fletcher CV, Federici ME, Harris AT, Evans KD, Rutkiewicz VL, Shearer WT, Dunkle LM. Combination therapy with stavudine and didanosine in children with advanced human immunodeficiency virus infection: pharmacokinetic properties, safety, and immunologic and virologic effects. Pediatrics. 1996 Jun;97(6 Pt 1):886-90.
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, McKinney RE Jr, Nichols S, Mitchell WG, Yogev R, Hutcheon N. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. AIDS Clinical Trials Group 240 Team. Pediatrics. 1998 Feb;101(2):214-20. doi: 10.1542/peds.101.2.214.
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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11217
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 240
Identifier Type: -
Identifier Source: org_study_id