TDF Long Term Study

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of generic TDF from Governmental Pharmaceutical Organization (GPO) in HIV-infected children

Detailed Description
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TDF is a nucleotide reverse transcriptase inhibitor (NRTI) which can be taken only once per day and continues to have good efficacy even in patients who have resistance to other NNRTI in the absence of K65R mutation. TDF is a choice for patients with NRTI resistance, or those that require once-daily regimen to improve adherence. Currently, TDF has not been approved by the US FDA for children less than 18 years, but pediatricians has been using TDF in children who have treatment failure because of limitation of a more appropriate pediatric ARV. The Thai national guideline for pediatric 2009 recommend the use of TDF in children who have failed the first line therapy with multi-NRTI mutation and are more than 30 kilograms or have tanner stage 4 or more. However, the problem is that there is no pediatric TDF formulation. The available preparation of 300 mg tear drop tablet, if cut in half, may increase dosing errors, more or less by 18-37%. This will affect the blood level and/or toxicities. Therefore, the Thai Governmental Pharmaceutical Organization (GPO) has produced a generic TDF formulation that can be used in HIV-infected children. This study will assess the safety and efficacy information in children using this generic pediatric TDF formulation.

Official Title
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Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children

Conditions
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HIV-infected Thai Children

Intervention / Treatment
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* Drug: tenofovir (TDF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children who are changing to TDF due to adherence problem or treatment failure children who are already on TDF due to their clinical indication Exclusion Criteria: child/caretaker refuse to participate in this study cannot adhere to the study schedule

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tenofovir (TDF)<br>HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication | Drug: tenofovir (TDF)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| viral load | Number of patients who have viral load less than 50 copies/ml at week 48 and week 96 | week 48 and 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal status | Number of patients with renal toxicity assessed by GFR and with proximal tubular effect | weeks 24, 48, 72, and 96 | 
| adherence | Agreement between self reported adherence by visual analogue scale (VAS) pill count and TDM Sensitivity and specificity of self-reported adherence and pill count against gold standards of TDM and undetectable viral load | every 3 months | 
| resistance | Resistant mutations in patients who fail TDF-based regimen and response to new regimen | every 3 months | 
| adverse events | Proportion of patients who develop adverse events which are related to TDF and other ARVs | weeks 24, 48, 72, and 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thai, TDF-based regimen, HIV-infected children, generic, safety and efficacy, renal status, To assess effect of TDF on renal problem in HIV-infected children receiving TDF-based once daily regimen, To compare the effectiveness and clinical usefulness of different tools of adherence