Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Zidovudine, Nevirapine, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: IVIG and opportunistic infection prophylaxis will be allowed. Erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony- stimulating factor (GM-CSF) will be allowed for the management of hematologic toxicity. Treatment with trimethoprim is allowed at the discretion of the principal investigator. Patients must have: Laboratory evidence (at least 2 viral tests) of HIV-1 infection. Clinical and immunological stability [maintained CDC category 1 or 2 immunologic status for past 4 months and no new CDC category (diagnosis within the past year)]. Patients must have received continuous antiretroviral therapy for the past 16 weeks (missing no more than 6 weeks of therapy during the previous 16 weeks). AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Viral load >= 10,000 and < 100,000 copies/ml at week 12, 24, or 36 in children initially assigned to Arm I (ZDV + 3TC) of PRAM-1 and currently on study. Prior Medication: Required: Patients must have received continuous antiretroviral therapy for the past 16 weeks. Allowed: Patients who have received immunomodulator therapy as part of perinatal clinical trials or in trials for HIV- exposed infants are eligible. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current grade 3/4 clinical or laboratory toxicity and/or current grade 2 or higher amylase/lipase toxicity. Active opportunistic infection and/or serious bacterial infection. Current diagnosis of malignancy. Concurrent Medication: Excluded: Current antiretroviral therapy identical to any of the following regimens: ZDV + 3TC, d4T + ritonavir and ZDV + 3TC + ritonavir. Concurrent therapy with any other anti-HIV-1 therapy, biologic response modifiers (EPO, G-CSF and GM-CSF allowed), human growth hormone and megestrol acetate. Use of continuous systemic corticosteroids (>= 14 days duration) is not allowed. Medications that are incompatible with ritonavir. Probenecid and daily intravenous pentamidine. [AS PER AMENDMENT 10/23/98: The following are excluded in patients receiving indinavir: terfenadine, astemizole, cisapride, rifampin, rifabutin, triazolam, ketoconazole, clarithromycin, carbamazepine, phenobarbital, phenytoin, calcium channel blockers, midazolam, and ergot derivatives.] Patients with the following prior conditions and symptoms are excluded: Documented hypersensitivity to a therapy included in any of the treatment arms. Prior Medication: Excluded: Investigational drug therapy within 2 weeks prior to randomization. NOTE: Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection protocols is allowed.
Sites / Locations
- Univ of Alabama at Birmingham - Pediatric
- 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
- UCSF / Moffitt Hosp - Pediatric
- Univ of Connecticut / Farmington
- Yale Univ Med School
- Children's Hosp of Washington DC
- Howard Univ Hosp
- North Broward Hosp District
- Univ of Florida Gainesville
- Univ of Florida Health Science Ctr / Pediatrics
- Univ of Miami (Pediatric)
- Palm Beach County Health Dept
- Emory Univ Hosp / Pediatrics
- 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
- Children's Hosp of Boston
- Boston City Hosp / Pediatrics
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med School
- Univ of Mississippi Med Ctr
- 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 at Albany Med Ctr
- Bronx Lebanon Hosp Ctr
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- King's County Hosp Ctr / Pediatrics
- SUNY - Brooklyn
- North Shore Univ Hosp
- Schneider Children's Hosp
- Bellevue Hosp / New York Univ Med Ctr
- Cornell Univ Med College
- Metropolitan Hosp Ctr
- Mount Sinai Med Ctr / Pediatrics
- Columbia Presbyterian Med Ctr
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
- Harlem Hosp Ctr
- Univ of Rochester Med Ctr
- State Univ of New York at Stony Brook
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
- Westchester Hosp
- Duke Univ Med Ctr
- Columbus Children's Hosp
- Saint Christopher's Hosp for Children
- Med Univ of South Carolina
- Children's Med Ctr of Dallas
- Texas Children's Hosp / Baylor Univ
- Med College of Virginia
- Children's Hospital & Medical Center / Seattle ACTU
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
- Univ of Puerto Rico / Univ Children's Hosp AIDS
- San Juan City Hosp