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

Completed

• Conditions: This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
• Interventions: Drug: Tenofovir

• Registration Number: NCT01225406
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-21
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
third line naive	Tenofovir	Children on second line or other regimen who switch or start third line regimen
third line experienced	Tenofovir	children who are on third line regimen

Primary Outcome Measures

Name	Time	Method
undetectable viral load	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

Name	Time	Method
Hyperlipidemia	48 weeks	Number of subjects with hyperlipidemia as a measure of safety

Trial Locations

Locations (9)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand

HIV-NAT; 🇹🇭 Bangkok, Thailand

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

Prapokklao Chantaburi; 🇹🇭 Chantaburi, Thailand

Nakornping Hospital; 🇹🇭 Chiang Mai, Thailand

Chiang Rai Regional Hospital; 🇹🇭 Chiang Rai, Thailand

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

Bamrasnaradura Institute; 🇹🇭 Nonthaburi, Thailand

Surin Hospital; 🇹🇭 Surin, Thailand