Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chulalongkorn University | OTHER |
| Bamrasnaradura Infectious Diseases Institute | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tenofovir (TDF) | HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenofovir (TDF) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| viral load | Number of patients who have viral load less than 50 copies/ml at week 48 and week 96 | week 48 and 96 |
| Measure | Description | Time Frame |
|---|---|---|
| renal status | Number of patients with renal toxicity assessed by GFR and with proximal tubular effect | weeks 24, 48, 72, and 96 |
| adherence | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based regimen
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wasana Prasitsuebsai, MD | The HIV Netherlands Australia Thailand Research Collaboration | Principal Investigator |
| Jurai Wongsawat, MD | Bamrasnadura Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV-NAT | Bangkok | 10330 | Thailand | |||
| King Chulalongkorn Hospital, Chulalongkorn University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
Not provided
Not provided
Not provided
Not provided
Not provided
Phlebotomy will be for safety evaluation and will be drawn according to the schedule of visit.
| every 3 months |
| resistance | Resistant mutations in patients who fail TDF-based regimen and response to new regimen | every 3 months |
| adverse events | Proportion of patients who develop adverse events which are related to TDF and other ARVs | weeks 24, 48, 72, and 96 |
| Bangkok |
| 10330 |
| Thailand |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |