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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Adefovir; Adefovir dipivoxil; Nelfinavir

Criteria

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.