A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
NCT ID: NCT00001066
Last Updated: 2011-03-02
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
PHASE2
740 participants
INTERVENTIONAL
Brief Summary
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Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
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Detailed Description
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Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.
Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Lamivudine
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* IVIG.
* Prophylaxis for opportunistic infection.
* EPO.
* G-CSF or GM-CSF.
Patients must have:
* Symptomatic HIV infection.
* Less than 56 days of prior antiretroviral therapy.
* Consent of parent or guardian.
NOTE:
* Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.
Prior Medication:
Allowed:
* Up to 56 days of prior antiretroviral therapy.
* Prior immunomodulator therapy.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Malignancy.
* Hypersensitivity to a nucleoside analog.
* Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.
PER AMENDMENT 4/29/96:
* Active opportunistic infection and/or serious bacterial infection at the time of entry.
Concurrent Medication:
Excluded:
* Any other anti-HIV therapy.
* Megestrol acetate ( Megace ).
* Probenecid.
* IV pentamidine.
* Human growth hormone ( hGH ).
* Systemic corticosteroids for more than 2 weeks.
Prior Medication:
Excluded:
* Investigational drug therapy within 14 days prior to study entry.
3 Months
15 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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McKinney RE
Role: STUDY_CHAIR
Johnson GM
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States
Arkansas Children's Hosp
Little Rock, Arkansas, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States
Los Angeles County - USC 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
Univ of California / Davis
Sacramento, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Stanford Univ School of Medicine
Stanford, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Yale Univ Med School
New Haven, Connecticut, 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
Children's Diagnostic and Treatment Ctr of South Florida
Fort Lauderdale, Florida, United States
Univ of Florida
Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Arnold Palmer Hosp for Children & Women
Orlando, Florida, United States
All Children's Hosp
St. Petersburg, Florida, United States
Univ of South Florida
Tampa, Florida, United States
Saint Joseph's Hosp
Tampa, Florida, United States
HRS Palm Beach County Public Health Unit
West Palm Beach, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Med College of Georgia
Augusta, Georgia, United States
Mem Children's Hosp
Savannah, Georgia, United States
Mount Sinai Hosp Med Ctr
Chicago, Illinois, 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
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 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 School
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Minnesota Med School
Minneapolis, Minnesota, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
St Louis Children's Hosp
St Louis, Missouri, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, 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
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
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
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
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Westchester Hosp
Valhalla, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States
Case Western Reserve Univ - Pediatric
Cleveland, Ohio, United States
Columbus Children's Hosp
Columbus, Ohio, United States
Children's Med Ctr
Dayton, Ohio, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Univ of South Carolina School of Med
Columbia, 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
Cook - Fort Worth Children's Med Ctr
Fort Worth, Texas, United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Univ of Texas Health Science Ctr
San Antonio, Texas, United States
Senetara Norfolk Gen Hosp
Norfolk, Virginia, United States
Virginia Commonwealth Univ
Richmond, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Mayaguez Med Ctr
Mayagüez, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Combination therapies improve outlook for children with HIV disease. NIAID AIDS Agenda. 1997 Aug:10.
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
James JS. Major pediatric study stopped early: combination treatment better. AIDS Treat News. 1997 Jul 4;(No 274):5-6.
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.
Benjamin DK Jr, Miller WC, Benjamin DK, Ryder RW, Weber DJ, Walter E, McKinney RE. A comparison of height and weight velocity as a part of the composite endpoint in pediatric HIV. AIDS. 2003 Nov 7;17(16):2331-6. doi: 10.1097/00002030-200311070-00007.
Other Identifiers
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ACTG 300
Identifier Type: -
Identifier Source: org_study_id
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