NCT02404259

Brief Summary

This study will assess the pharmacokinetics of TDF in Thai HIV-infected children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

February 7, 2013

Last Update Submit

March 30, 2015

Conditions

HIV

Keywords

pharmacokineticsTDFHIV-infected childrenThainon-nucleoside reverse transcriptase inhibitor (NNRTI)ritonavir-boosted protease inhibitor (bPI)less than eighteen years old

Outcome Measures

Primary Outcomes (1)

  • area under the curve (AUC) (pharmacokinetics of TDF)

    pharmacokinetics of TDF in children between the ages of 8-18 years

    12 months

Study Arms (2)

non-nucleoside reverse transcriptase inhibitor (NNRTI)

OTHER

Efavirenz

Drug: TDF (Tenofovir)Drug: Efavirenz

ritonavir-boosted protease inhibitor

OTHER

lopinavir/ritonavir atazanavir/ritonavir

Drug: TDF (Tenofovir)Drug: lopinavir/ritonavir, atazanavir/ritonavir

Interventions

TDF (Tenofovir)DRUG
non-nucleoside reverse transcriptase inhibitor (NNRTI)ritonavir-boosted protease inhibitor
EfavirenzDRUG
non-nucleoside reverse transcriptase inhibitor (NNRTI)
lopinavir/ritonavir, atazanavir/ritonavirDRUG
ritonavir-boosted protease inhibitor

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children between the ages of 8-18 years with documented HIV infection
  • currently on TDF once daily regimen
  • have signed the informed consent

You may not qualify if:

  • the child or care taker refuse to participate in the study
  • severity of adverse events is more than grade 3 thirty days before participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related Links

MeSH Terms

Interventions

TenofovirefavirenzLopinavirRitonaviratazanavir, ritonavir drug combination

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingThiazolesSulfur CompoundsAzoles

Study Officials

  • Thanyawee Puthanakit, MD

    HIV-NAT and Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

March 31, 2015

Study Start

June 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

TH(1)