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.

Study Overview

• Status: Completed
• Conditions: This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
• Intervention / Treatment: 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
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • HIV-NAT
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol University
  • Bangkok, Thailand, 10330
    • Chulalongkorn University
  • Chantaburi, Thailand, 22000
    • Prapokklao Chantaburi
  • Chiang Mai, Thailand, 50180
    • Nakornping Hospital
  • Chiang Rai, Thailand, 57000
    • Chiang Rai Regional Hospital
  • Khon Kaen, Thailand, 40002
    • Khon Kaen University
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Institute
  • Surin, Thailand, 32000
    • Surin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperlipidemia	Number of subjects with hyperlipidemia as a measure of safety	48 weeks

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: National Health Security Office, Thailand; Ministry of Education, Thailand
• Investigators: Principal Investigator: Thanyawee Puthanakit, MD, Chulalongkorn University Bangkok; Principal Investigator: Kulkanya Chokephaibulkit, MD, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Publications and helpful links

General Publications

• 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.

Helpful Links

• The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 21, 2010

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Drug resistance; Third line ARV therapy; HIV RNA; Absolute CD4+ T cell count; serious adverse events (SAEs)
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: HIV-NAT 113