To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the
better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected
children who received less than 56 days of prior antiretroviral therapy. To evaluate the
safety and tolerance of 3TC/AZT in this patient population. To determine other measures of
diseases in response to the study regimens.
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.
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.
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
Mayaguez Med Ctr, Mayaguez 00680, Puerto Rico
Univ of Alabama at Birmingham Schl of Med / Pediatrics, Birmingham, Alabama 35294, United States
Arkansas Children's Hosp, Little Rock, Arkansas 72202, United States
UCSF / Moffitt Hosp - Pediatric, San Francisco, California 941430105, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California 905022004, United States
Children's Hosp of Oakland, Oakland, California 946091809, United States
UCLA Med Ctr / Pediatric, Los Angeles, California 900951752, United States
Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles, California 900276016, United States
Long Beach Memorial (Pediatric), Long Beach, California 90801, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Univ of California / Davis, Sacramento, California 958172208, United States
Stanford Univ School of Medicine, Stanford, California 943054149, United States
Children's Hosp of Denver, Denver, Colorado 802181088, United States
Yale Univ Med School, New Haven, Connecticut 06504, 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
All Children's Hosp, St. Petersburg, Florida 33701, United States
Children's Diagnostic and Treatment Ctr of South Florida, Fort Lauderdale, Florida 33301, United States
Univ of Florida, Gainesville, Florida 32610, United States
Univ of South Florida, Tampa, Florida 33606, United States
Arnold Palmer Hosp for Children & Women, Orlando, Florida 32806, United States
HRS Palm Beach County Public Health Unit, West Palm Beach, Florida 33407, United States
Saint Joseph's Hosp, Tampa, Florida 33614, United States
Emory Univ Hosp / Pediatrics, Atlanta, Georgia 30306, United States
Mem Children's Hosp, Savannah, Georgia 31404, United States
Med College of Georgia, Augusta, Georgia 30912, United States
Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois 60612, United States
Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States
Mount Sinai Hosp Med Ctr, Chicago, Illinois 60608, 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
Johns Hopkins Hosp - Pediatric, Baltimore, Maryland 212874933, United States
Children's Hosp of Boston, Boston, Massachusetts 021155724, United States
Boston City Hosp / Pediatrics, Boston, Massachusetts 02118, United States
Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States
Univ of Massachusetts Med School, Worcester, Massachusetts 016550001, United States
Children's Hosp of Michigan, Detroit, Michigan 48201, United States
Univ of Minnesota Med School, Minneapolis, Minnesota 55455, United States
Univ of Mississippi Med Ctr, Jackson, Mississippi 392165405, United States
St Louis Children's Hosp, St. Louis, Missouri 63110, 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
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey 07103, 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
Westchester Hosp, Valhalla, New York 10595, United States
Schneider Children's Hosp, New Hyde Park, New York 11040, United States
Univ of Rochester Medical Center, Rochester, New York 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, 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
Children's Hosp at Albany Med Ctr, Albany, New York 12208, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10457, United States
State Univ of New York at Stony Brook, Stony Brook, New York 117948111, United States
Beth Israel Med Ctr / Pediatrics, New York, New York 10003, United States
Children's Hosp of Buffalo, Buffalo, New York 14222, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Case Western Reserve Univ - Pediatric, Cleveland, Ohio 44106, United States
Cincinnati Children's Hosp / Univ Hosp, Cincinnati, Ohio 452292899, United States
Columbus Children's Hosp, Columbus, Ohio 432052696, United States
Children's Med Ctr, Dayton, Ohio 454041518, United States
Children's Hosp of Philadelphia, Philadelphia, Pennsylvania 191044318, United States
Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania 191341095, United States
Rhode Island Hosp / Brown Univ, Providence, Rhode Island 02903, United States
Med Univ of South Carolina, Charleston, South Carolina 294253312, United States
Univ of South Carolina School of Med, Columbia, South Carolina 29203, United States
Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States
Children's Med Ctr of Dallas, Dallas, Texas 75235, United States
Hermann Hosp / Univ Texas Health Science Ctr, Houston, Texas 77030, United States
Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States
Cook - Fort Worth Children's Med Ctr, Fort Worth, Texas 76104, United States
Univ of Texas Health Science Ctr, San Antonio, Texas 78240, United States
Senetara Norfolk Gen Hosp, Norfolk, Virginia 23507, United States
Virginia Commonwealth Univ, Richmond, Virginia 232980413, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington 981050371, United States
[No authors listed] Combination therapies improve outlook for children with HIV disease. NIAID AIDS Agenda. 1997 Aug;:10. No abstract available.
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. No abstract available.
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.
Benjamin Jr DK, 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):2331-2336.
