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
  Purpose

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.


Condition Intervention
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy.
Drug: Tenofovir

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Hyperlipidemia [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Number of subjects with hyperlipidemia as a measure of safety


Biospecimen Retention:   Samples Without DNA

Plasma and PBMC


Enrollment: 56
Study Start Date: August 2010
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
third line naive
Children on second line or other regimen who switch or start third line regimen
Drug: Tenofovir
third line experienced
children who are on third line regimen
Drug: Tenofovir

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225406

Locations
Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
HIV-NAT
Bangkok, Thailand, 10330
Chulalongkorn University
Bangkok, Thailand, 10330
Prapokklao Chantaburi
Chantaburi, Thailand, 22000
Nakornping Hospital
Chiang Mai, Thailand, 50180
Chiang Rai Regional Hospital
Chiang Rai, Thailand, 57000
Khon Kaen University
Khon Kaen, Thailand, 40002
Bamrasnaradura Institute
Nonthaburi, Thailand, 11000
Surin Hospital
Surin, Thailand, 32000
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Commission of higher education (CHE), Ministry of Education, Thailand
National Health Security Office, Thailand
Investigators
Principal Investigator: Thanyawee Puthanakit, MD Chulalongkorn University, Bangkok
Principal Investigator: Kulkanya Chokephaibulkit, MD Siriraj Hospital, Mahidol University, Bangkok, Thailand
  More Information

Additional Information:
Publications:
Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01225406     History of Changes
Other Study ID Numbers: HIV-NAT 113
Study First Received: October 18, 2010
Last Updated: March 26, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
Third line ARV therapy
HIV RNA
Absolute CD4+ T cell count
serious adverse events (SAEs)
Drug resistance

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 27, 2015