Children With HIV and Asthma (CHIVAS)
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ClinicalTrials.gov Identifier: NCT01644370 |
Recruitment Status
:
Completed
First Posted
: July 19, 2012
Last Update Posted
: February 22, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment | Drug: HAART | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
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)
|
- 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

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644370
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 |
Principal Investigator: | Praphan Phanuphak, MD, PhD | The HIV Netherlands Australia Thailand Research Collaboration |
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 |
First Posted: | July 19, 2012 Key Record Dates |
Last Update Posted: | February 22, 2016 |
Last Verified: | February 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 |