TDF Long Term Study

• ClinicalTrials.gov Identifier: NCT01815255
• Recruitment Status: Completed
• First Posted: March 21, 2013
• Last Update Posted: July 17, 2020
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Chulalongkorn University; Bamrasnaradura Infectious Diseases Institute
• Information provided by (Responsible Party): The HIV Netherlands Australia Thailand Research Collaboration

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
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

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

• 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

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

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 Infectious Diseases 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 

Publications of Results:

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
• Other Study ID Numbers: HIV-NAT 133
• First Posted: March 21, 2013
• Last Update Posted: July 17, 2020
• Last Verified: July 2020

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

Additional relevant MeSH terms:

Tenofovir; 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