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

2014-08-27 03:59:14 | BioPortfolio

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.

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Nelfinavir mesylate, Levocarnitine, Adefovir dipivoxil

Location

All Children's Hosp
St. Petersburg
Florida
United States
33731

Status

Active, not recruiting

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:14-0400

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Medical and Biotech [MESH] Definitions

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