A Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients.
Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination
with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met,
patients may have the option to switch to open-label treatment for the remainder of the
study period.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
United States: Food and Drug Administration
238L
NCT00002391
Name | Location |
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Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
Med Univ of South Carolina | Charleston, South Carolina 294253312 |
Univ of Texas Health Sciences Ctr | San Antonio, Texas 782847838 |
Tulane Univ Med School | New Orleans, Louisiana 70112 |
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station | Birmingham, Alabama 35294 |
Children's Hosp Los Angeles | Los Angeles, California 90027 |
Children's Diagnostic Treatment Ctr | Fort Lauderdale, Florida 33301 |
Univ of Florida - Gainesville / Infectious Dis & Immun | Gainesville, Florida 326100296 |
Univ of Miami / Fox Cancer Research Ctr | Miami, Florida 33136 |
Arnold Palmer Hosp for Women and Children | Orlando, Florida 32806 |
Pediatric Special Immunology Clinic / HRS / PBC PHU | Riviera Beach, Florida 33404 |
Univ of South Florida All Children's Hosp | Saint Petersburg, Florida 33701 |
Dr Patricia Emmanuel | Tampa, Florida 33606 |
Mt Sinai Hosp Med Ctr / Dept of Pediatrics | Chicago, Illinois 60608 |
Univ of Minnesota Med School | Minneapolis, Minnesota 55455 |
UMDNJ / Division of Allergy Immunology & Infectious Diseases | Newark, New Jersey 07103 |
Bronx Lebanon Hosp Ctr / Dept of Pediatrics | Bronx, New York 10457 |
PACT Program | Buffalo, New York 14222 |
North Shore Univ Hosp / Pediatric Immunology | Great Neck, New York 11021 |
Schneider Children's Hosp | New Hyde Park, New York 11040 |
New York Hosp - Cornell / Program for Children with AIDS | New York, New York 10021 |
St Luke's - Roosevelt Hosp Ctr | New York, New York 10025 |
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis | Stony Brook, New York 117948111 |
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics | Syracuse, New York 13210 |
Univ of North Carolina / Pediatric Infectious Diseases | Chapel Hill, North Carolina 27514 |
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis | Durham, North Carolina 27710 |
The Children's Med Ctr / Division of Infectious Dis | Dayton, Ohio 454041815 |
Children's Med Ctr of Dallas / ARMS Clinic | Dallas, Texas 75235 |
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis | Fort Worth, Texas 76104 |
Eastern VA Med Sch / Children's Hosp of the King's Daughters | Norfolk, Virginia 23507 |