Children With HIV and Asthma (CHIVAS)

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644370
• Other study ID #: HIV-NAT 102
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: February 19, 2016
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Drug:
• HAART
as per Thai HIV Treatment guidelines

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Chulalongkorn University, National Health Security Office, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell response	exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation	24 weeks	No

External Links

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