Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00002219
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
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 (7)
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
🇺🇸Bronx, New York, United States
St Lukes Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Tulane Univ Med Ctr / Dept of Pediatrics
🇺🇸New Orleans, Louisiana, United States
All Children's Hosp
🇺🇸St. Petersburg, Florida, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
North Shore Univ Hosp / Division of Immunology
🇺🇸Great Neck, New York, United States
Duke Univ Med Ctr / Duke South Hosp
🇺🇸Durham, North Carolina, United States