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

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ClinicalTrials.gov Identifier: NCT01225406
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
Ministry of Education, Thailand
National Health Security Office, Thailand
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary:
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 or disease Intervention/treatment
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy 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


Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Other
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
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tenofovir

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. undetectable viral load [ Time Frame: 48 weeks ]
    Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.


Secondary Outcome Measures :
  1. Hyperlipidemia [ Time Frame: 48 weeks ]
    Number of subjects with hyperlipidemia as a measure of safety


Biospecimen Retention:   Samples Without DNA
Plasma and PBMC


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225406


Locations
Thailand
Chulalongkorn University
Bangkok, Thailand, 10330
HIV-NAT
Bangkok, Thailand, 10330
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
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
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

Additional Information:
Publications of Results:
Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01225406     History of Changes
Other Study ID Numbers: HIV-NAT 113
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

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:
Tenofovir
Reverse Transcriptase Inhibitors
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents