Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children

This study has been completed.
Sponsor:
Collaborators:
Commission of higher education (CHE), Ministry of Education, Thailand
National Health Security Office, Thailand
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01225406
First received: October 18, 2010
Last updated: March 26, 2015
Last verified: March 2015

October 18, 2010
March 26, 2015
August 2010
August 2013   (final data collection date for primary outcome measure)
undetectable viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.
Same as current
Complete list of historical versions of study NCT01225406 on ClinicalTrials.gov Archive Site
Hyperlipidemia [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Number of subjects with hyperlipidemia as a measure of safety
Same as current
Not Provided
Not Provided
 
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy

This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.

The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.

Third line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples Without DNA
Description:

Plasma and PBMC

Non-Probability Sample

Thai children aged < 18 years old who are on or are switching to third line antiretroviral therapy

This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy.
Drug: Tenofovir
  • third line naive
    Children on second line or other regimen who switch or start third line regimen
    Intervention: Drug: Tenofovir
  • third line experienced
    children who are on third line regimen
    Intervention: Drug: Tenofovir
Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1-infected children aged ≥7 years. Antivir Ther. 2012;17(7):1263-9. doi: 10.3851/IMP2347. Epub 2012 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
December 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met:

  1. Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA > 1000 copies/ml prior to switching to third line ARV therapy
  2. Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir

Exclusion Criteria:

  1. Have hepatic impairment with ALT ≥ 5 upper limit of normal
  2. Pregnant or breastfeeding
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01225406
HIV-NAT 113
No
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • Commission of higher education (CHE), Ministry of Education, Thailand
  • National Health Security Office, Thailand
Principal Investigator: Thanyawee Puthanakit, MD Chulalongkorn University, Bangkok
Principal Investigator: Kulkanya Chokephaibulkit, MD Siriraj Hospital, Mahidol University, Bangkok, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP