A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
- Conditions
- HIV Infections
- Registration Number
- NCT00000963
- Brief Summary
To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
- Detailed Description
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
🇺🇸Atlanta, Georgia, United States
Cook County Hosp.
🇺🇸Chicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
🇺🇸Chicago, Illinois, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
🇺🇸Farmington, Connecticut, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
🇺🇸Chicago, Illinois, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
🇺🇸New Orleans, Louisiana, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
UMDNJ - Robert Wood Johnson
🇺🇸New Brunswick, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
🇺🇸Paterson, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
🇺🇸Albany, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
Metropolitan Hosp. NICHD CRS
🇺🇸New York, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
🇺🇸Great Neck, New York, United States
Schneider Children's Hosp., Div. of Infectious Diseases
🇺🇸New Hyde Park, New York, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Incarnation Children's Ctr.
🇺🇸New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
🇺🇸Charleston, South Carolina, United States
Children's Med. Ctr. Dallas
🇺🇸Dallas, Texas, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
🇵🇷Bayamon, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States