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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Nelfinavir mesylate  Drug: Levocarnitine  Drug: Adefovir dipivoxil	Phase II

Further Study Details: 

Expected Total Enrollment:  36

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.

Ages Eligible for Study:  3 Months   -   16 Years,  Genders Eligible for Study:  Both

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.

Florida
      All Children's Hosp, St. Petersburg,  Florida,  33731,  United States
Louisiana
      Tulane Univ Med Ctr / Dept of Pediatrics, New Orleans,  Louisiana,  70112,  United States
New York
      St Lukes Roosevelt Hosp Ctr, New York,  New York,  10025,  United States
      North Shore Univ Hosp / Division of Immunology, Great Neck,  New York,  11021,  United States
      Bronx Lebanon Hosp Ctr / Dept of Pediatrics, Bronx,  New York,  10457,  United States
North Carolina
      Duke Univ Med Ctr / Duke South Hosp, Durham,  North Carolina,  27710,  United States
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  29425,  United States

Study ID Numbers:  232H; GS-97-418
Record last reviewed:  November 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002219
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08