Status:

COMPLETED

Efficacy and Safety of Single Versus Double Ritonavir-boosted Protease Inhibitor (PI)-Based Antiretroviral Therapy (ART) Regimens

Lead Sponsor:

The HIV Netherlands Australia Thailand Research Collaboration

Collaborating Sponsors:

Ministry of Education, Thailand

Conditions:

HIV Infection

HIV Infections

Eligibility:

All Genders

1-18 years

Brief Summary

The virological efficacy will be no different in children treated with single versus double boosted PI second line ART regimens.

Detailed Description

A total of 50,620 Thai children have been diagnosed with HIV infection in Thailand between 1988 and 2005, of whom only 20,000 are still living.1 The production of generic ART by the Thai Government Ph...

Eligibility Criteria

Inclusion

  • Children (\< 18 years old) with HIV infection
  • Have failed NNRTI-based ART
  • Received second-line regimen with either one or two boosted PIs (Note: low dose ritonavir to boost the other PI will not be count as additional PI)
  • Began ritonavir-boosted PI prior to June 30, 2007

Exclusion

  • Have previously received PI treatment for longer than 30 days prior to the current PI regimen.
  • Has previously or currently been treated with abacavir or tenofovir
  • Currently on ART other than NRTI, NNRTI and PI drug classes

Key Trial Info

Start Date :

October 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00886990

Start Date

October 1 2007

End Date

April 1 2009

Last Update

July 17 2020

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Petchburi Hospital

Petchburi, Petchburi, Thailand

2

HIV-NAT

Bangkok, Thailand, 10330

3

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

4

Siriraj Hospital, Mahidol University

Bangkok, Thailand