Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments nelfinavir mesylate, levocarnitine, adefovir dipivoxil
Phase phase 2
Sponsor Gilead Sciences
Trial size 36 participants
Trial identifier NCT00002219, 232H, GS-97-418

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Primary purpose treatment

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.