TDF Long Term Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Chulalongkorn University
Bamrasnaradura Institute
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01815255
First received: February 7, 2013
Last updated: March 20, 2013
Last verified: March 2013

February 7, 2013
March 20, 2013
December 2010
January 2014   (final data collection date for primary outcome measure)
viral load [ Time Frame: week 48 and 96 ] [ Designated as safety issue: Yes ]
Number of patients who have viral load less than 50 copies/ml at week 48 and week 96
Same as current
Complete list of historical versions of study NCT01815255 on ClinicalTrials.gov Archive Site
  • renal status [ Time Frame: weeks 24, 48, 72, and 96 ] [ Designated as safety issue: Yes ]
    Number of patients with renal toxicity assessed by GFR and with proximal tubular effect
  • adherence [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    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
  • resistance [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
    Resistant mutations in patients who fail TDF-based regimen and response to new regimen
  • adverse events [ Time Frame: weeks 24, 48, 72, and 96 ] [ Designated as safety issue: Yes ]
    Proportion of patients who develop adverse events which are related to TDF and other ARVs
Same as current
Not Provided
Not Provided
 
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

Phlebotomy will be for safety evaluation and will be drawn according to the schedule of visit.

Non-Probability Sample

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

HIV-infected Thai Children
Not Provided
TDF
HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
35
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01815255
HIV-NAT 133
No
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • Chulalongkorn University
  • Bamrasnaradura Institute
Principal Investigator: Wasana Prasitsuebsai, MD The HIV Netherlands Australia Thailand Research Collaboration
Principal Investigator: Jurai Wongsawat, MD Bamrasnadura Institute
The HIV Netherlands Australia Thailand Research Collaboration
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP