A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP). Immunoglobulin. Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week. Concurrent Treatment: Allowed: Blood transfusions. Prior Medication: Allowed: Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP). Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study. Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144. Patient or guardian available to give written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded. Hypersensitivity to didanosine (ddI). Symptomatic cardiomyopathy. Seizures that are not well controlled by ongoing anticonvulsant therapy. Symptomatic pancreatitis. Grade 1 or higher peripheral neuropathy. Active malignancy requiring chemotherapy. Concurrent Medication: Excluded: Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications. Avoid: Drugs with potential to cause peripheral neuropathy or pancreatitis. Patients with the following are excluded: Active malignancy requiring concomitant chemotherapy. Prior Medication: Excluded: Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry. Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry. Any other experimental therapy within 1 week of entry. Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
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
- 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 Med. Ctr. - Charity Hosp. of New Orleans, ACTU
- Tulane/LSU Maternal/Child CRS
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- 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 Stony Brook NICHD CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- DUMC Ped. CRS
- Case 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
- Children's Med. Ctr. Dallas
- Texas Children's Hosp. CRS
- 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