A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: Intravenous and/or intramuscular immunoglobulin. Acyclovir (no more than 30 mg/kg/day PO). Ketoconazole (no more than 10 mg/kg/day). Nystatin. Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours. Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy. Trimethoprim / sulfamethoxazole. Amphotericin B (no more than 1 mg/kg for 5 days/week). Aerosolized ribavirin for bronchiolitis. Hematopoietic agents. Other drugs with little nephro-, hepato-, or cytotoxicity. Nutritional support for HIV wasting syndrome or malnutrition. Patients must have: HIV infection. Ongoing stable AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols. Known allergy or sensitivity to ddC. Cardiomyopathy. Concurrent Medication: Excluded: Biologic modifiers other than IVIG, steroids, or hematopoietic agents. Investigational medications unless approved by protocol chair. Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given). Patients with the following prior conditions are excluded: History of intolerance or toxicity to AZT. History of symptomatic pancreatitis. History of peripheral neuropathy or abnormal nerve conduction velocity test. Prior Medication: Excluded: Antiretroviral agents other than AZT within 2 weeks of study entry. Required: Ongoing stable AZT therapy for more than 6 weeks duration.
Sites / Locations
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Usc La Nichd Crs
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSD Maternal, Child, and Adolescent HIV CRS
- San Francisco Gen. Hosp.
- UCSF Pediatric AIDS CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Connecticut Health Ctr., Dept. of Ped.
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Children's National Med. Ctr., ACTU
- Howard Univ. Washington DC NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
- Cook County Hosp.
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
- Chicago Children's CRS
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Tulane/LSU Maternal/Child CRS
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- Children's Hospital of Michigan NICHD CRS
- UMDNJ - Robert Wood Johnson
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
- Children's Hospital at Albany Medical Center, Dept. of Peds.
- Bronx-Lebanon Hosp. IMPAACT CRS
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- North Shore-Long Island Jewish Health System, Dept. of Peds.
- Schneider Children's Hosp., Div. of Infectious Diseases
- NYU Med. Ctr., Dept. of Medicine
- Metropolitan Hosp. NICHD CRS
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- Univ. of Rochester ACTG CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- DUMC Ped. CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- St. Christopher's Hosp. for Children
- Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
- UW School of Medicine - CHRMC
- Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
- San Juan City Hosp. PR NICHD CRS
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS