Children With HIV and Asthma (CHIVAS)

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

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-12-31

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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HIV positive with aeroallergen

positive for aeroallergen at baseline

Group Type OTHER

HAART

Intervention Type DRUG

as per Thai HIV Treatment guidelines

HIV positive without aeroallergen

negative for aeroallergen at baseline

Group Type OTHER

HAART

Intervention Type DRUG

as per Thai HIV Treatment guidelines

control

HIV negative children (n=10)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HAART

as per Thai HIV Treatment guidelines

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Children aged 2-18 years
2. Parent signed inform consent and children signed assent form
3. 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

1. Pregnancy
2. History of chronic lung disease including lymphoid interstitial pneumonitis (LIP), and bronchopulmonary dysplasia (BPD).
3. Active opportunistic infections i.e. pulmonary tuberculosis, PCP, pneumonia
4. Conditions limiting ability of subject to comprehend questionnaires (i.e. mental retardation).

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes