T Cell Response to Asthma in HIV-infected Patients Before and After Starting TreatmentNCT01644370
Children With HIV and Asthma (CHIVAS)
A study testing HAART in people with T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
Trial summary
To explore allergen-specific effector and regulatory T cell response in HIV-infected children before and after HAART initiation Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment
- What is being tested?
- HAART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
The King Chulalongkorn Memorial Hospital, Chulalongkorn University, Division of Allergy & Immunology, Department of Pediatrics
Bangkok, 10330
About this study
Official title: 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
Read the 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.
- Being tested
- HAART
- Keywords
- HIV-infected children, T cell response, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAARTDrug
as per Thai HIV Treatment guidelines
| Study group | Role | What they receive |
|---|---|---|
| HIV positive with aeroallergen | Other | positive for aeroallergen at baseline Receives: Drug: HAART |
| HIV positive without aeroallergen | Other | negative for aeroallergen at baseline Receives: Drug: HAART |
| control | No intervention | HIV negative children (n=10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell response
exploring T cell response by immunophenotyping and cytokine detection in HIV-infected children before and after HAART initiation
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell Response to Asthma in HIV-infected Patients Before and After Starting TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, National Health Security Office, Thailand
- Responsible party
- Sponsor
- Investigators
- Praphan Phanuphak, MD, PhD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644370
- Sponsor's protocol ID
- HIV-NAT 102
- Status last verified
- Feb 2016
- First submitted
- 17 Jul 2012
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergen Specific T Effector and T Regulatory Cell Response to Common Aeroallergens Following Immune Restoration in HIV-infected Children
- ClinicalTrials.gov ID
- NCT01644370
- Acronym / sponsor ID
- HIV-NAT 102
- Keywords
- HIV-infected children, T cell response, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, National Health Security Office, Thailand
- Study start
- Sep 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV positive with aeroallergen | Other | Drug: HAARTpositive for aeroallergen at baseline |
| HIV positive without aeroallergen | Other | Drug: HAARTnegative for aeroallergen at baseline |
| control | No intervention | –HIV negative children (n=10) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAARTas per Thai HIV Treatment guidelines | Drug | HIV positive with aeroallergen, HIV positive without aeroallergen |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praphan Phanuphak, MD, PhD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAART in people with T Cell Response to Asthma in HIV-infected Patients Before and After Starting Treatment, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T cell response (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.