Clinical trial NCT01815255: TDF Long Term Study
Official title: Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-infected Thai Children
Keywords: 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
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
name: Bamrasnaradura Infectious Diseases Institute
First posted: 2013-03-21
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based regimen

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

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 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

Primary outcomes:
measure: viral load
timeFrame: week 48 and 96
Secondary outcomes:
measure: renal status
timeFrame: weeks 24, 48, 72, and 96
measure: adherence
timeFrame: every 3 months
measure: resistance
timeFrame: every 3 months
measure: adverse events
timeFrame: weeks 24, 48, 72, and 96
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
city: Bangkok
country: Thailand
facility: King Chulalongkorn Hospital, Chulalongkorn University
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Wasana Prasitsuebsai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bamrasnadura Institute
name: Jurai Wongsawat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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