Children With HIV and Asthma (CHIVAS)

Study Overview
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Brief Summary
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To explore allergen-specific effector and regulatory T cell response in HIV-infected children before and after HAART initiation

Detailed Description
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Recently, US investigators have observed that HIV-infected (HIV+) children on highly active antiretroviral therapy (HAART) have a much greater cumulative incidence of asthma.Regulatory T cells may mitigate the pathogenicity of asthma through the suppression of Th2 responses. Since asthma is predominantly a TH2 mediated condition, we propose that new onset of asthma after HAART in HIV- infected children may be secondary to dysregulated immune reconstitution. The restoration of CD4+ T cell-mediated immunity in HIV+ patients treated with HAART may lead to airway inflammation, narrowing, hyperresponsiveness, and possibly remodeling. The increased incidence of asthma in HIV-infected children treated with HAART is likely secondary to multiple factors that may include hypersensitivity to certain aeroallergens, dysregulation of effector and regulatory T cell response, as well as the imbalance of TH1 vs. TH2 cytokines. Therefore this study will identify the immunopathogenesis of increased airway hyperresponsiveness in HIV-positive patients.

Official Title
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Allergen Specific T Effector and T Regulatory Cell Response to Common Aeroallergens Following Immune Restoration in HIV-infected Children

Conditions
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T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment

Intervention / Treatment
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* Drug: HAART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 2-18 years Parent signed inform consent and children signed assent form Children who are starting highly active antiretroviral therapy (HAART) due to clinical indication or switching HAART due to treatment failure within 45 days after screening visit Exclusion Criteria: Pregnancy History of chronic lung disease including lymphoid interstitial pneumonitis (LIP), and bronchopulmonary dysplasia (BPD). Active opportunistic infections i.e. pulmonary tuberculosis, PCP, pneumonia Conditions limiting ability of subject to comprehend questionnaires (i.e. mental retardation).

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIV positive with aeroallergen<br>positive for aeroallergen at baseline | Drug: HAART<br>* as per Thai HIV Treatment guidelines<br>|
| Other: HIV positive without aeroallergen<br>negative for aeroallergen at baseline | Drug: HAART<br>* as per Thai HIV Treatment guidelines<br>|
| No Intervention: control<br>HIV negative children (n=10) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell response | exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-infected children, T cell response, asthma