Skip to main content
OpenTrials
Completed

NCT Number: NCT01644370

Children With HIV and Asthma (CHIVAS)

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HAART

Drug

as per Thai HIV Treatment guidelines

Primary outcomes

  1. T cell response

    Time frame: 24 weeks

    exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Chulalongkorn University
  • National Health Security Office, Thailand

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 19, 2012
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.