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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-12-31

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.

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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third line naive

Children on second line or other regimen who switch or start third line regimen

Tenofovir

Intervention Type DRUG

third line experienced

children who are on third line regimen

Tenofovir

Intervention Type DRUG

Interventions

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Tenofovir

Intervention Type DRUG

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:

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