A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
Clinical Trial: A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination with Zidovudine in HIV-1 Infected Children
This study has been completed.
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.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Lamivudine |
|Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Expected Total Enrollment: 740
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.
Ages Eligible for Study: 3 Months - 15 Years, Genders Eligible for Study: Both
Concurrent Medication: Allowed:
- Prophylaxis for opportunistic infection.
- G-CSF or GM-CSF.
Patients must have:
- Symptomatic HIV infection.
- Less than 56 days of prior antiretroviral therapy.
- Consent of parent or guardian.
- 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.
Co-existing Condition: Patients with the following symptoms or conditions are excluded:
- 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:
Concurrent Medication: Excluded:
- Any other anti-HIV therapy.
- Megestrol acetate ( Megace ).
- IV pentamidine.
- Human growth hormone ( hGH ).
- Systemic corticosteroids for more than 2 weeks.
Prior Medication: Excluded:
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
District of Columbia
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
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
McKinney RE, Study Chair
Johnson GM, Study Chair
Click here for more information about Zidovudine
Click here for more information about Didanosine
Click here for more information about Lamivudine
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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.
Record last reviewed: November 1998
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00001066
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005