Children With HIV and Asthma (CHIVAS)

Allergen Specific T Effector and T Regulatory Cell Response to Common Aeroallergens Following Immune Restoration in HIV-infected Children

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

Study Overview

• Status: Completed
• Conditions: T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment
• Intervention / Treatment: Drug: HAART

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HIV positive with aeroallergen; positive for aeroallergen at baseline	Drug: HAART; as per Thai HIV Treatment guidelines
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell response	exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation	24 weeks

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Chulalongkorn University; National Health Security Office, Thailand
• Investigators: Principal Investigator: Praphan Phanuphak, MD, PhD, The HIV Netherlands Australia Thailand Research Collaboration

Publications and helpful links

Helpful Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 19, 2012

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 19, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: asthma; T cell response; HIV-infected children
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HIV-NAT 102