A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
- Conditions
- HIV Infections
- Registration Number
- NCT00000653
- Brief Summary
To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy.
As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
- Detailed Description
As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
Patients receive oral ddC for 48 to 177 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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 (35)
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, 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
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
🇺🇸Atlanta, Georgia, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
Cook County Hosp.
🇺🇸Chicago, Illinois, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
UMDNJ - Robert Wood Johnson
🇺🇸New Brunswick, New Jersey, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
🇺🇸Chicago, Illinois, United States
Schneider Children's Hosp., Div. of Infectious Diseases
🇺🇸New Hyde Park, New York, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
🇵🇷Bayamon, Puerto Rico
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
🇺🇸Great Neck, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
🇺🇸New Orleans, Louisiana, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Metropolitan Hosp. NICHD CRS
🇺🇸New York, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
🇺🇸Chapel Hill, North Carolina, United States