A Study to Compare Two Different Anti-HIV Drug Regimens
A Phase II Randomized, Multicenter Protocol Evaluating Two Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs, and an NNRTI
5 other identifiers
interventional
120
2 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are between 4 months and 21 years of age (consent of parent or guardian required if under 18).
- Are HIV-positive.
- Have a viral level of at least 4,000 copies/ml.
- Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months.
- Have received the same continuous antiretroviral therapy for the past 16 weeks.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have an active opportunistic and/or serious bacterial infection.
- Have been diagnosed with a malignancy.
- Have received prior treatment with certain antiretroviral medications.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Univ of South Alabama
Mobile, Alabama, 36604, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Children's Hosp of Oakland
Oakland, California, 946091809, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33311, United States
Univ of Florida Gainesville
Gainesville, Florida, 32610, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, 70112, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103, United States
North Shore Univ Hosp
Great Neck, New York, 11021, United States
Schneider Children's Hosp
New Hyde Park, New York, 11040, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507, United States
Med College of Virginia
Richmond, Virginia, 23219, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (1)
King JR, Nachman S, Yogev R, Hodge J, Aldrovandi G, Hughes MD, Chen J, Wiznia A, Damle B, Acosta EP. Efficacy, tolerability and pharmacokinetics of two nelfinavir-based regimens in human immunodeficiency virus-infected children and adolescents: pediatric AIDS clinical trials group protocol 403. Pediatr Infect Dis J. 2005 Oct;24(10):880-5. doi: 10.1097/01.inf.0000180508.21918.8a.
PMID: 16220085RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrew Wiznia