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

Status unconfirmed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002219

Run by

Gilead Sciences

People needed

36

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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