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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
History of Changes
  Purpose

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


Condition
HIV-infected Thai Children

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   None Retained

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


Enrollment: 35
Study Start Date: December 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TDF
HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815255

Locations
Thailand
HIV-NAT
Bangkok, Thailand, 10330
King Chulalongkorn Hospital, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
Bamrasnaradura Institute
Investigators
Principal Investigator: Wasana Prasitsuebsai, MD The HIV Netherlands Australia Thailand Research Collaboration
Principal Investigator: Jurai Wongsawat, MD Bamrasnadura Institute
  More Information

Additional Information:
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01815255     History of Changes
Other Study ID Numbers: HIV-NAT 133
Study First Received: February 7, 2013
Last Updated: March 20, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
TDF-based regimen
HIV-infected children
Thai
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

ClinicalTrials.gov processed this record on May 19, 2013