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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

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

Intervention / Treatment
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* Drug: Tenofovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met: 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 Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir Exclusion Criteria: Have hepatic impairment with ALT ≥ 5 upper limit of normal Pregnant or breastfeeding

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| third line naive<br>Children on second line or other regimen who switch or start third line regimen | Drug: Tenofovir<br> <br> |
| third line experienced<br>children who are on third line regimen | Drug: Tenofovir<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Third line ARV therapy, HIV RNA, Absolute CD4+ T cell count, serious adverse events (SAEs), Drug resistance