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TDF Long Term Study

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ClinicalTrials.gov Identifier: NCT01815255
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
HIV-infected Thai Children 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 Design

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children
Study Start Date : December 2010
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

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)

Outcome Measures

Primary Outcome Measures :
  1. viral load [ Time Frame: week 48 and 96 ]
    Number of patients who have viral load less than 50 copies/ml at week 48 and week 96

Secondary Outcome Measures :
  1. renal status [ Time Frame: weeks 24, 48, 72, and 96 ]
    Number of patients with renal toxicity assessed by GFR and with proximal tubular effect

  2. adherence [ Time Frame: every 3 months ]
    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

  3. resistance [ Time Frame: every 3 months ]
    Resistant mutations in patients who fail TDF-based regimen and response to new regimen

  4. adverse events [ Time Frame: weeks 24, 48, 72, and 96 ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815255

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

Additional Information:
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

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01815255     History of Changes
Other Study ID Numbers: HIV-NAT 133
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents