Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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.
Inclusion Criteria

 Your child may be eligible for this study if he/she:

 -  Is 3 months to 16 years old.

 -  Is HIV-positive.

 -  Has never taken protease inhibitors or has previously taken ritonavir (RTV),
 saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study
 entry.

 -  Is taking an anti-HIV drug combination that will not change during at least the 2
 weeks prior to study entry.

 -  Agrees to use effective barrier methods of birth control, such as condoms, during the
 study.

 -  Has consent of parent or guardian.

 Exclusion Criteria

 Your child will not be eligible for this study if he/she:

 -  Has ever taken NFV.

 -  Has a history of opportunistic (AIDS-related) infection.

 -  Has any disease or illness that would prevent him/her from completing the study,
 including cancer.

 -  Has taken certain medications, including protease inhibitors at study entry.

 -  Is receiving an HIV vaccine at study entry.

 -  Is pregnant.