HIV-infected Thai Children
Conditions
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
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.
Interventions
DRUGtenofovir (TDF)
Sponsors
Chulalongkorn University
Bamrasnaradura Infectious Diseases Institute
The HIV Netherlands Australia Thailand Research Collaboration
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| viral load | week 48 and 96 | Number of patients who have viral load less than 50 copies/ml at week 48 and week 96 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| renal status | weeks 24, 48, 72, and 96 | Number of patients with renal toxicity assessed by GFR and with proximal tubular effect |
| adherence | 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 |
| resistance | every 3 months | Resistant mutations in patients who fail TDF-based regimen and response to new regimen |
| adverse events | weeks 24, 48, 72, and 96 | Proportion of patients who develop adverse events which are related to TDF and other ARVs |
Countries
Thailand
Outcome results
None listed