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Children With HIV and Asthma (CHIVAS)

This study is currently recruiting participants.
Verified July 2012 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
Collaborators:
Chulalongkorn University
Thai National Health Security Office (NHSO)
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01644370
First received: July 17, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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


Condition Intervention
T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment
 Drug: HAART

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Allergen Specific T Effector and T Regulatory Cell Response to Common Aeroallergens Following Immune Restoration in HIV-infected Children

Resource links provided by NLM:

MedlinePlus related topics: Asthma HIV/AIDS
U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • allergen-specific effector and regulatory T cell response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HIV positive with aeroallergen
positive for aeroallergen at baseline
 Drug: HAART
as per Thai HIV Treatment guidelines
HIV positive without aeroallergen
negative for aeroallergen at baseline
 Drug: HAART
as per Thai HIV Treatment guidelines
No Intervention: control
HIV negative children (n=10)

Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644370

Contacts
Contact: Torsak Bunupuradah, MD 662-652-3040 torsak.b@hivnat.org

Locations
Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) Recruiting
Bangkok, Thailand, 10330
Contact: Praphan Phanuphak, MD, PhD     662-652-3040     praphan.p@chula.ac.th    
Contact: Torsak Bunupuradah, MD     662-652-3040     torsak.b@hivnat.org    
Principal Investigator: Torsak Bunupuradah, MD            
The King Chulalongkorn Memorial Hospital, Chulalongkorn University, Division of Allergy & Immunology, Department of Pediatrics Recruiting
Bangkok, Thailand, 10330
Contact: Pantipa Chatchatee, MD     66-2-256 4990     pantipa1111@yahoo.com    
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
Thai National Health Security Office (NHSO)
Investigators
Principal Investigator: Praphan Phanuphak, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
  More Information

Additional Information:
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01644370     History of Changes
Other Study ID Numbers: HIV-NAT 102
Study First Received: July 17, 2012
Last Updated: July 17, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV-infected children
T cell response
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013