TDF Long Term Study

HIV-infected Thai Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815255
• Other study ID #: HIV-NAT 133
• Status: Completed
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-infected Thai Children

Intervention

Drug:
• tenofovir (TDF)

Locations

Country	Name	City	State
Thailand	HIV-NAT	Bangkok
Thailand	King Chulalongkorn Hospital, Chulalongkorn University	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 21

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	renal status	Number of patients with renal toxicity assessed by GFR and with proximal tubular effect	weeks 24, 48, 72, and 96
Secondary	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
Secondary	resistance	Resistant mutations in patients who fail TDF-based regimen and response to new regimen	every 3 months
Secondary	adverse events	Proportion of patients who develop adverse events which are related to TDF and other ARVs	weeks 24, 48, 72, and 96

External Links

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