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Report for Clinical Trial NCT01815255

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT01815255 HIV-infected Thai Children

1 Interventions

Name: tenofovir (TDF)

Type: Drug
Group Labels: 1

tenofovir (TDF)


Primary Outcomes

Description: Number of patients who have viral load less than 50 copies/ml at week 48 and week 96

Measure: viral load

Time: week 48 and 96

Secondary Outcomes

Description: Number of patients with renal toxicity assessed by GFR and with proximal tubular effect

Measure: renal status

Time: weeks 24, 48, 72, and 96

Description: 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

Measure: adherence

Time: every 3 months

Description: Resistant mutations in patients who fail TDF-based regimen and response to new regimen

Measure: resistance

Time: every 3 months

Description: Proportion of patients who develop adverse events which are related to TDF and other ARVs

Measure: adverse events

Time: weeks 24, 48, 72, and 96

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 K65R

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 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 HIV-infected Thai Children 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. --- K65R ---



HPO Nodes