A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
NCT ID: NCT00000637
Last Updated: 2021-11-02
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
PHASE3
819 participants
INTERVENTIONAL
1996-09-30
Brief Summary
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Detailed Description
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Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for \> 72 hours.
* Systemic ketoconazole and fluconazole for acute therapy.
Recommended:
* Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis.
Patients must have the following:
* HIV infection.
* Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted.
Prior Medication:
Allowed:
* Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Active malignancy.
* Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
* History of uncontrolled seizure disorder.
* Grade 3 or higher peripheral neuropathy.
* Cardiomyopathy.
Concurrent Medication:
Excluded:
* Chemotherapy for malignancy.
* Oral acidifying agents.
* Acetaminophen, ibuprofen, or aspirin on a continual basis for \> 72 hours.
* Ketoconazole or fluconazole for prophylaxis.
* Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for \> 4 weeks.
Patients with the following are excluded:
* Active malignancy.
* Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
* History of uncontrolled seizure disorder.
* Grade 3 or higher peripheral neuropathy.
Prior Medication:
Excluded:
* Steroids.
* Intravenous immunoglobulin.
* Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for \> 6 weeks and within 7 days prior to study entry.
Prior Treatment:
Excluded:
* Red blood cell transfusion within four weeks prior to study entry.
Ongoing drug or alcohol use.
3 Months
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Baker C
Role: STUDY_CHAIR
Englund J
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Stanford Univ School of Medicine / Pediatrics
Stanford, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Univ of Connecticut Health Ctr
Farmington, Connecticut, United States
Yale Univ Med School
New Haven, Connecticut, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
St Louis Univ School of Medicine
St Louis, Missouri, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States
SUNY - Brooklyn
Brooklyn, New York, United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Beth Israel Med Ctr / Pediatrics
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Cornell Univ Med College
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Metropolitan Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Lincoln Hosp Ctr
The Bronx, New York, United States
Bronx Lebanon Hosp Ctr / Pediatrics
The Bronx, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Westchester Hosp
Valhalla, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
Columbus Children's Hosp
Columbus, Ohio, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hosp of Seattle
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
UPR Children's Hosp / UPR School of Medicine
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Raskino C, Pearson DA, Baker CJ, Lifschitz MH, O'Donnell K, Mintz M, Nozyce M, Brouwers P, McKinney RE, Jimenez E, Englund JA. Neurologic, neurocognitive, and brain growth outcomes in human immunodeficiency virus-infected children receiving different nucleoside antiretroviral regimens. Pediatric AIDS Clinical Trials Group 152 Study Team. Pediatrics. 1999 Sep;104(3):e32. doi: 10.1542/peds.104.3.e32.
Grubman S. Pediatric treatment update. GMHC Treat Issues. 1996 Mar;10(3):7-9.
Glick ME. CTG studies yield results. AIDS Clinical Trials Group. NIAID AIDS Agenda. 1995 Spring:8-9.
Rogers MF, Mofenson LM, Moseley RR. Reducing the risk of perinatal HIV transmission through zidovudine therapy: treatment recommendations and implications. J Am Med Womens Assoc (1972). 1995 May-Aug;50(3-4):78-82, 93.
Nielsen K, Wei LS, Sim MS, Deveikis A, Keller M, Stiehm ER, Frenkel LM, Bryson YJ. Correlation of clinical progression in human immunodeficiency virus-infected children with in vitro zidovudine resistance measured by a direct quantitative peripheral blood lymphocyte assay. J Infect Dis. 1995 Aug;172(2):359-64. doi: 10.1093/infdis/172.2.359.
Palumbo PE, Raskino C, Fiscus S, Pahwa S, Fowler MG, Spector SA, Englund JA, Baker CJ. Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children. JAMA. 1998 Mar 11;279(10):756-61. doi: 10.1001/jama.279.10.756.
McKinney RE Jr, Wilfert C. Growth as a prognostic indicator in children with human immunodeficiency virus infection treated with zidovudine. AIDS Clinical Trials Group Protocol 043 Study Group. J Pediatr. 1994 Nov;125(5 Pt 1):728-33. doi: 10.1016/s0022-3476(94)70065-6.
James JS. AZT, ddI, and ddC combinations at FDA advisory hearing. Food and Drug Administration. AIDS Treat News. 1996 Apr 5;(no 244):6.
Englund JA, Baker CJ, McKinney RE, Raskino CL, Fowler MG, Lifschitz MC. Results of ACTG 152, a randomized comparative trial of zidovudine (ZDV), didanosine (ddI), and ZDV/ddI combination therapy in symptomatic HIV-infected children. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:213 (abstract no I150)
Englund JA, Baker CJ, Raskino C, McKinney RE, Petrie B, Fowler MG, Pearson D, Gershon A, McSherry GD, Abrams EJ, Schliozberg J, Sullivan JL. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. AIDS Clinical Trials Group (ACTG) Study 152 Team. N Engl J Med. 1997 Jun 12;336(24):1704-12. doi: 10.1056/NEJM199706123362403.
Capparelli EV, Englund JA, Connor JD, Spector SA, McKinney RE, Palumbo P, Baker CJ. Population pharmacokinetics and pharmacodynamics of zidovudine in HIV-infected infants and children. J Clin Pharmacol. 2003 Feb;43(2):133-40. doi: 10.1177/0091270002239821.
Chantry CJ, Byrd RS, Englund JA, Baker CJ, McKinney RE Jr; Pediatric AIDS Clinical Trials Group Protocol 152 Study Team. Growth, survival and viral load in symptomatic childhood human immunodeficiency virus infection. Pediatr Infect Dis J. 2003 Dec;22(12):1033-9. doi: 10.1097/01.inf.0000100575.64298.bc.
Other Identifiers
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11127
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 152
Identifier Type: -
Identifier Source: org_study_id