TDF Long Term Study

NCT ID: NCT01815255

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-08-31

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.

Conditions

HIV-infected Thai Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

tenofovir (TDF)

HIV-infected children who are currently on TDF-based regimen or are changing to TDF based on their clinical indication

tenofovir (TDF)

Intervention Type: DRUG

Interventions

tenofovir (TDF)

Intervention Type: DRUG

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: collaborator

Bamrasnaradura Infectious Diseases Institute

OTHER_GOV

Sponsor Role: collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wasana Prasitsuebsai, MD

Role: PRINCIPAL_INVESTIGATOR

The HIV Netherlands Australia Thailand Research Collaboration

Jurai Wongsawat, MD

Role: PRINCIPAL_INVESTIGATOR

Bamrasnadura Institute

Locations

HIV-NAT

Bangkok, , Thailand

King Chulalongkorn Hospital, Chulalongkorn University

Bangkok, , Thailand

Countries

Thailand

References

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

Reference Type: RESULT

Related Links

http://www.hivnat.org

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website

Other Identifiers

HIV-NAT 133

Identifier Type: -

Identifier Source: org_study_id