A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
- Conditions
- HIV Infections
- Registration Number
- NCT00000814
- Brief Summary
To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
- Detailed Description
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks.
AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
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 (68)
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Univ of Pittsburgh Med School / Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Rhode Island Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Beth Israel Med Ctr / Pediatrics
🇺🇸New York, New York, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
🇺🇸New York, New York, United States
Westchester Hosp
🇺🇸Valhalla, New York, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Univ of Connecticut / Farmington
🇺🇸Farmington, Connecticut, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
King's County Hosp Ctr / Pediatrics
🇺🇸Brooklyn, New York, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
🇺🇸New Brunswick, New Jersey, United States
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
West Central Ohio Hemophilia Ctr / Children's Med Ctr
🇺🇸Dayton, Ohio, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico