TDF Long Term Study

NCT01815255 | Completed

• 1 other identifier: HIV-NAT 133
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• viral load

  Number of patients who have viral load less than 50 copies/ml at week 48 and week 96

  week 48 and 96

Secondary Outcomes (4)

• renal status

  weeks 24, 48, 72, and 96

• adherence

  every 3 months

• resistance

  every 3 months

• adverse events

  weeks 24, 48, 72, and 96

Study Arms (1)

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)

Interventions

tenofovir (TDF) DRUG

tenofovir (TDF)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected children who are currently taking or are changing to tenofovir-(TDF) based regimen

You may qualify if:

• children who are changing to TDF due to adherence problem or treatment failure
• children who are already on TDF due to their clinical indication

You may not qualify if:

• child/caretaker refuse to participate in this study
• cannot adhere to the study schedule

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Chulalongkorn University: collaborator
• Bamrasnaradura Infectious Diseases Institute: collaborator

Study Sites (2)

HIV-NAT

Bangkok, 10330, Thailand

Location

King Chulalongkorn Hospital, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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

  RESULT

Related Links

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

Biospecimen

Retention: NONE RETAINED

Phlebotomy will be for safety evaluation and will be drawn according to the schedule of visit.

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wasana Prasitsuebsai, MD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

• Jurai Wongsawat, MD

  Bamrasnadura Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: March 21, 2013
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (2)