Trial record 18 of 28 for: " July 04, 2012":" August 03, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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Children With HIV and Asthma (CHIVAS)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01644370

First Posted: July 19, 2012

Last Update Posted: February 22, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Chulalongkorn University

National Health Security Office, Thailand

Information provided by (Responsible Party):

The HIV Netherlands Australia Thailand Research Collaboration

Purpose

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

Condition	Intervention
T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment	Drug: HAART


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:

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


Enrollment:	20
Study Start Date:	September 2011
Study Completion Date:	December 2015
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility

Information from the National Library of Medicine

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

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).

Contacts and Locations

Information from the National Library of Medicine

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

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

Additional Information:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site


Responsible Party:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT01644370 History of Changes
Other Study ID Numbers:	HIV-NAT 102
First Submitted:	July 17, 2012
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

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