A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Lamivudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: 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 Co-existing Condition: 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.
Sites / Locations
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
- Arkansas Children's Hosp
- UCSD Med Ctr / Pediatrics / Clinical Sciences
- Long Beach Memorial (Pediatric)
- Children's Hosp of Los Angeles/UCLA Med Ctr
- Los Angeles County - USC Med Ctr
- UCLA Med Ctr / Pediatric
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- Children's Hosp of Oakland
- Univ of California / Davis
- UCSF / Moffitt Hosp - Pediatric
- Stanford Univ School of Medicine
- Children's Hosp of Denver
- Univ of Connecticut / Farmington
- Yale Univ Med School
- Children's Hosp of Washington DC
- Howard Univ Hosp
- Children's Diagnostic and Treatment Ctr of South Florida
- Univ of Florida
- Univ of Florida Health Science Ctr / Pediatrics
- Univ of Miami (Pediatric)
- Arnold Palmer Hosp for Children & Women
- All Children's Hosp
- Univ of South Florida
- Saint Joseph's Hosp
- HRS Palm Beach County Public Health Unit
- Emory Univ Hosp / Pediatrics
- Med College of Georgia
- Mem Children's Hosp
- Mount Sinai Hosp Med Ctr
- Cook County Hosp
- Univ of Illinois College of Medicine / Pediatrics
- Chicago Children's Memorial Hosp
- Univ of Chicago Children's Hosp
- Tulane Univ / Charity Hosp of New Orleans
- Univ of Maryland at Baltimore / Univ Med Ctr
- Johns Hopkins Hosp - Pediatric
- Children's Hosp of Boston
- Boston City Hosp / Pediatrics
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med School
- Children's Hosp of Michigan
- Univ of Minnesota Med School
- Univ of Mississippi Med Ctr
- St Louis Children's Hosp
- UMDNJ - Robert Wood Johnson Med School / Pediatrics
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
- Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
- Children's Hosp at Albany Med Ctr
- Bronx Lebanon Hosp Ctr
- King's County Hosp Ctr / Pediatrics
- SUNY - Brooklyn
- Children's Hosp of Buffalo
- North Shore Univ Hosp
- Schneider Children's Hosp
- Beth Israel Med Ctr / Pediatrics
- Bellevue Hosp / New York Univ Med Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Metropolitan Hosp Ctr
- Mount Sinai Med Ctr / Pediatrics
- Columbia Presbyterian Med Ctr
- Harlem Hosp Ctr
- Univ of Rochester Medical Center
- State Univ of New York at Stony Brook
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
- Westchester Hosp
- Duke Univ Med Ctr
- Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
- Cincinnati Children's Hosp / Univ Hosp
- Case Western Reserve Univ - Pediatric
- Columbus Children's Hosp
- Children's Med Ctr
- Children's Hosp of Philadelphia
- Saint Christopher's Hosp for Children
- Rhode Island Hosp / Brown Univ
- Med Univ of South Carolina
- Univ of South Carolina School of Med
- Saint Jude Children's Research Hosp of Memphis
- Children's Med Ctr of Dallas
- Cook - Fort Worth Children's Med Ctr
- Hermann Hosp / Univ Texas Health Science Ctr
- Texas Children's Hosp / Baylor Univ
- Univ of Texas Health Science Ctr
- Senetara Norfolk Gen Hosp
- Virginia Commonwealth Univ
- Children's Hospital & Medical Center / Seattle ACTU
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
- Mayaguez Med Ctr
- Univ of Puerto Rico / Univ Children's Hosp AIDS
- San Juan City Hosp