Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
This trial is active, not recruiting.
|Treatments||nelfinavir mesylate, levocarnitine, adefovir dipivoxil|
|Trial size||36 participants|
|Trial identifier||NCT00002219, 232H, GS-97-418|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|St. Petersburg, FL||All Children's Hosp||no longer recruiting|
|New Orleans, LA||Tulane Univ Med Ctr / Dept of Pediatrics||no longer recruiting|
|Bronx, NY||Bronx Lebanon Hosp Ctr / Dept of Pediatrics||no longer recruiting|
|Great Neck, NY||North Shore Univ Hosp / Division of Immunology||no longer recruiting|
|New York, NY||St Lukes Roosevelt Hosp Ctr||no longer recruiting|
|Durham, NC||Duke Univ Med Ctr / Duke South Hosp||no longer recruiting|
|Charleston, SC||Med Univ of South Carolina||no longer recruiting|
|Endpoint classification||safety study|
Male or female participants from 3 months up to 16 years old.
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.
|Official title||A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients|
|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.|
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