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Trial record 18 of 28 for:
" July 04, 2012":" August 03, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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 ]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) |
| Sexes Eligible for Study: | All |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
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 July 19, 2017