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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01225406

Enrollment

Registered

2010-10-21

Start date

2010-08-31

Completion date

2013-12-31

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy

Keywords

Third line ARV therapy, HIV RNA, Absolute CD4+ T cell count, serious adverse events (SAEs), Drug resistance

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

Interventions

DRUGTenofovir

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026