Children With HIV and Asthma (CHIVAS)
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
Chulalongkorn University
National Health Security Office, Thailand
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01644370
First received: July 17, 2012
Last updated: February 19, 2016
Last verified: February 2016
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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:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- 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
| Enrollment: | 20 |
| Study Start Date: | September 2011 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | July 2014 (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 (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01644370
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644370
Locations
| Thailand | |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
| Bangkok, Thailand, 10330 | |
| The King Chulalongkorn Memorial Hospital, Chulalongkorn University, Division of Allergy & Immunology, Department of Pediatrics | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
National Health Security Office, Thailand
Investigators
| Principal Investigator: | Praphan Phanuphak, MD, PhD | The HIV Netherlands Australia Thailand Research Collaboration |
More Information
Additional Information:
| 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: | February 19, 2016 |
| 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 September 27, 2016