Children With HIV and Asthma (CHIVAS)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment	Drug: HAART	Not Applicable

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) 

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
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