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Children With HIV and Asthma (CHIVAS)

T

The HIV Netherlands Australia Thailand Research Collaboration

Status

Completed

Conditions

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

Treatments

Drug: HAART

Study type

Interventional

Funder types

Other

Identifiers

NCT01644370
HIV-NAT 102

Details and patient eligibility

About

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

Full description

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.

Enrollment

20 patients

Sex

All

Ages

2 to 18 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 3 patient groups

HIV positive with aeroallergen
Other group
Description:
positive for aeroallergen at baseline
Treatment:
Drug: HAART
HIV positive without aeroallergen
Other group
Description:
negative for aeroallergen at baseline
Treatment:
Drug: HAART
control
No Intervention group
Description:
HIV negative children (n=10)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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