A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
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
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: Acetaminophen if not on a continual basis. NOTE: Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution. Patients must have at least one of the following: Documented HIV infection. Been born to an HIV-infected woman and receiving AZT. PER AMENDMENT 4/8/97: Number 2 above no longer required with closure of Part A of study. Patients must have signed, informed consent of parent or legal guardian. PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age. PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age. NOTE: All patients must have been more than 34 weeks gestation at birth. Prior Medication: Allowed: Prior vaccine therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Pancreatitis. Clinically unstable condition. Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status. Concurrent Medication: Excluded: Vaccine therapy. Patients with the following prior condition are excluded: Pancreatitis at any time since birth. Prior Medication: Excluded in Part B patients only: More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.
Sites / Locations
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
- UCSD Med Ctr / Pediatrics / Clinical Sciences
- Long Beach Memorial (Pediatric)
- Los Angeles County - USC Med Ctr
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- Children's Hosp of Oakland
- San Francisco Gen Hosp
- UCSF / Moffitt Hosp - Pediatric
- Children's Hosp of Denver
- Univ of Connecticut / Farmington
- Children's Hosp of Washington DC
- Howard Univ Hosp
- North Broward Hosp District
- Univ of Florida Health Science Ctr / Pediatrics
- Univ of Miami (Pediatric)
- Palm Beach County Health Dept
- 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
- Children's Hosp of Boston
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med School
- Children's Hosp of Michigan
- 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
- Schneider Children's Hosp
- 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 Medical Center
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
- Duke Univ Med Ctr
- Children's Hosp of Philadelphia
- Saint Christopher's Hosp for Children
- Med Univ of South Carolina
- Children's Hosp of the King's Daughters
- Med College of Virginia
- Univ of Puerto Rico / Univ Children's Hosp AIDS
- San Juan City Hosp