A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
- Conditions
- HIV Infections
- Registration Number
- NCT00001032
- Brief Summary
PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children.
SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria.
In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
- Detailed Description
In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
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 (47)
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, 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
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
🇺🇸Chicago, Illinois, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Usc La Nichd Crs
🇺🇸Los Angeles, California, 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
San Francisco Gen. Hosp.
🇺🇸San Francisco, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
🇺🇸Farmington, 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
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
Cook County Hosp.
🇺🇸Chicago, Illinois, 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
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
🇺🇸Albany, New York, 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
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
Schneider Children's Hosp., Div. of Infectious Diseases
🇺🇸New Hyde Park, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
🇺🇸Great Neck, New York, United States
Metropolitan Hosp. NICHD CRS
🇺🇸New York, New York, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Incarnation Children's Ctr.
🇺🇸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
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
🇺🇸Charleston, South Carolina, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
🇵🇷Bayamon, 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