A Study to Compare Two Different Anti-HIV Drug Regimens
- Conditions
- HIV Infections
- Registration Number
- NCT00000924
- Brief Summary
This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor (nevirapine).
These drug combinations have been previously studied in adults, but there is limited information on how well they work in HIV-infected children. It is important to develop drug combinations which are effective at suppressing the HIV virus in children.
- Detailed Description
The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children.
Patients are stratified by prior antiretroviral treatment (zidovudine \[ZDV\]/lamivudine \[3TC\] versus d4T/other treatment) and by age (under 24 months versus 24 months and older). Patients are then randomized to 1 of 4 treatment groups.
Arm A1: ddI/NFV/RTV (for prior ZDV/3TC-treated patients). Arm A2: ddI/NFV/RTV (for prior d4T/other-treated patients). Arm B1: d4T/NFV/NVP (for prior ZDV/3TC-treated patients). Arm B2: d4T/NFV/NVP (for prior d4T/other-treated patients). Treatment is administered for 48 weeks. At Weeks 2, 4, and then every 4 weeks thereafter, patients undergo physical examinations, and blood samples are drawn to measure viral load. \[AS PER AMENDMENT 4/27/00: Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks. While on the treatment extension, patients must continue their current schedule for study drug administration and completion of study visits. Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension. Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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 (45)
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Univ of South Alabama
🇺🇸Mobile, Alabama, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Earl K Long Early Intervention Clinic
🇺🇸New Orleans, Louisiana, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, 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
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States