The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
36
All Children's Hosp
St. Petersburg, Florida, United States
Tulane Univ Med Ctr / Dept of Pediatrics
New Orleans, Louisiana, United States
North Shore Univ Hosp / Division of Immunology
Great Neck, New York, United States
St Lukes Roosevelt Hosp Ctr
New York, New York, United States
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Bronx Lebanon Hosp Ctr / Dept of Pediatrics
The Bronx, New York, United States
Duke Univ Med Ctr / Duke South Hosp
Durham, North Carolina, United States
Med Univ of South Carolina
Charleston, South Carolina, United States