TDF Long Term Study

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

Study Overview

• Status: Completed
• Conditions: HIV-infected Thai Children
• Intervention / Treatment: Drug: tenofovir (TDF)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • HIV-NAT
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Hospital, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based regimen

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
tenofovir (TDF); HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication	Drug: tenofovir (TDF)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Chulalongkorn University; Bamrasnaradura Infectious Diseases Institute
• Investigators: Principal Investigator: Wasana Prasitsuebsai, MD, The HIV Netherlands Australia Thailand Research Collaboration; Principal Investigator: Jurai Wongsawat, MD, Bamrasnadura Institute

Publications and helpful links

General Publications

• Prasitsuebsai W, Puthanakit T, Apornpong T, Keadpudsa S, Bunupuradah T, Chuanjaroen T, Thammajaruk N, Jupimai T, Kerr SJ, Ananworanich J. Bone and Renal Safety at 96 weeks of TDF-containing in HIV-infected Thai children. Abstract # 905 presented at the 21st CROI 2014, March 3-6, 2014 at Boston, USA

Helpful Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Thai; renal status; HIV-infected children; safety and efficacy; generic; TDF-based regimen; 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
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: HIV-NAT 133