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Children With HIV and Asthma (CHIVAS)

Primary Purpose

T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
HAART
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment focused on measuring HIV-infected children, T cell response, asthma

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
  • The King Chulalongkorn Memorial Hospital, Chulalongkorn University, Division of Allergy & Immunology, Department of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

HIV positive with aeroallergen

HIV positive without aeroallergen

control

Arm Description

positive for aeroallergen at baseline

negative for aeroallergen at baseline

HIV negative children (n=10)

Outcomes

Primary Outcome Measures

T cell response
exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation

Secondary Outcome Measures

Full Information

First Posted
July 17, 2012
Last Updated
February 19, 2016
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Chulalongkorn University, National Health Security Office, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT01644370
Brief Title
Children With HIV and Asthma (CHIVAS)
Official Title
Allergen Specific T Effector and T Regulatory Cell Response to Common Aeroallergens Following Immune Restoration in HIV-infected Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Chulalongkorn University, National Health Security Office, Thailand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment
Keywords
HIV-infected children, T cell response, asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV positive with aeroallergen
Arm Type
Other
Arm Description
positive for aeroallergen at baseline
Arm Title
HIV positive without aeroallergen
Arm Type
Other
Arm Description
negative for aeroallergen at baseline
Arm Title
control
Arm Type
No Intervention
Arm Description
HIV negative children (n=10)
Intervention Type
Drug
Intervention Name(s)
HAART
Intervention Description
as per Thai HIV Treatment guidelines
Primary Outcome Measure Information:
Title
T cell response
Description
exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Praphan Phanuphak, MD, PhD
Organizational Affiliation
The HIV Netherlands Australia Thailand Research Collaboration
Official's Role
Principal Investigator
Facility Information:
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
The King Chulalongkorn Memorial Hospital, Chulalongkorn University, Division of Allergy & Immunology, Department of Pediatrics
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.hivnat.org
Description
HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

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Children With HIV and Asthma (CHIVAS)

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