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Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs

2014-08-27 03:56:54 | BioPortfolio

Summary

Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study is to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who have taken few or no anti-HIV drugs.

Description

Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults. This study will evaluate the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients.

Patients will be followed for a maximum of 192 weeks; all patients will receive ddI, EFV, and FTC together once daily. Study visits will occur at study entry, Weeks 2 and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam will occur at all visits; urine collection will occur at selected visits. Intensive pharmacokinetic (PK) studies will be done at Weeks 2 and 12 to determine if dose adjustments are required for any of the drugs. If virologic failure is determined, PK studies will be repeated 4 weeks after adjustments in therapy. Parents or guardians will be asked to complete treatment adherence questionnaires at some visits. Some patients may also be asked to participate in an additional PK study after Week 16 or week 96.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Didanosine, Efavirenz, Emtricitabine

Location

Univ of Alabama at Birmingham - Pediatric
Birmingham
Alabama
United States
35233

Status

Completed

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:54-0400

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