Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Antiviral Agents, Stavudine
Eligibility Criteria
Inclusion Criteria Patients must: Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment. Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody Have parent or legal guardian willing to sign a consent. Prior Medication: Required: On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Intractable diarrhea or vomiting. Current clinical or laboratory Grade 3 or worse toxicities. Concurrent Medication: Excluded: Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219. Chemotherapy for active malignancy. Patients with any of the following prior conditions are excluded: Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment. Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously. Subjects who have had chemotherapy for active malignancy. Prior Medication: Excluded: Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
Sites / Locations
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Colorado Denver NICHD CRS
- Univ. of Connecticut Health Ctr., Dept. of Ped.
- Connecticut Children's Med. Ctr.
- Children's National Med. Ctr., ACTU
- Howard Univ. Washington DC NICHD CRS
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Cook County Hosp.
- 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
- Children's Hospital of Michigan NICHD CRS
- UMDNJ - Robert Wood Johnson
- NJ Med. School CRS
- 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
- Metropolitan Hosp. NICHD CRS
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- DUMC Ped. 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
- 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