Children With HIV and Asthma (CHIVAS)

NCT01644370 | Completed

• 1 other identifier: HIV-NAT 102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

HIV-infected children; T cell response; asthma

Outcome Measures

Primary Outcomes (1)

• T cell response

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

  24 weeks

Study Arms (3)

HIV positive with aeroallergen

OTHER

positive for aeroallergen at baseline

Drug: HAART

HIV positive without aeroallergen

OTHER

negative for aeroallergen at baseline

Drug: HAART

control

NO INTERVENTION

HIV negative children (n=10)

Interventions

HAART DRUG

as per Thai HIV Treatment guidelines

HIV positive with aeroallergen; HIV positive without aeroallergen

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Chulalongkorn University: collaborator
• National Health Security Office, Thailand: collaborator

Study Sites (2)

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

Bangkok, 10330, Thailand

Location

The King Chulalongkorn Memorial Hospital, Chulalongkorn University, Division of Allergy & Immunology, Department of Pediatrics

Bangkok, 10330, Thailand

Location

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Praphan Phanuphak, MD, PhD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

TH (2)