TuberculosisPhase 2NCT00201123
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
A Phase 2 study testing Aerosol Interferon-Gamma and Subcutaneous interferon-gamma in people with Tuberculosis and AIDS-related Complex, run by NYU Langone Health at 2 sites in 2 countries.
Trial summary
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tuberculosis, AIDS-related Complex
- What is being tested?
- Aerosol Interferon-Gamma and Subcutaneous interferon-gamma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2005to Aug 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
- Cluster of Differentiation 4 greater than 200 if HIV positive
- Ability to sign consent
- Bilateral, cavitary pulmonary TB
Who cannot join
- Multidrug-resistant (MDR) TB
- Extrapulmonary TB
- HIV positive with opportunistic infection within 30 days of study entry
- Cancer
- Asthma
- Pregnant or lactating women
Show all 12Show fewer
- Chronic heart disease
- Chronic liver disease
- Chronic renal disease
- Seizure disorder
- Bleeding or clotting disorder
- Diabetes mellitus
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
The Lung Institute at University of Cape Town
Cape Town
About this study
Official title: Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
Read the detailed description
BACKGROUND:
Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.
DESIGN NARRATIVE:
Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.
The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.
The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.
- Conditions
- Tuberculosis, AIDS-related Complex
- Being tested
- Aerosol Interferon-Gamma, Subcutaneous interferon-gamma, Placebo
- Medical subject headings
- Tuberculosis, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosol Interferon-GammaDrug
Participants will receive aerosol interferon-gamma.
Subcutaneous interferon-gammaDrug
Patients will receive subcutaneous interferon-gamma
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Placebo comparator | Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy Receives: Other: Placebo |
| Aerosol Interferon-gamma | Experimental | Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide Receives: Drug: Aerosol Interferon-Gamma |
| Subcutaneous Interferon-Gamma | Experimental | Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide Receives: Drug: Subcutaneous interferon-gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Conversion
Measured: Measured at 16 Weeks
Secondary outcomes (2)
Chest Cavity Size
Measured: 16 Weeks
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William Rom, MD, MPH, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201123
- Sponsor's protocol ID
- 264
- Other IDs
- R01HL059832-06
- Status last verified
- Dec 2016
- First submitted
- 16 Sep 2005
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dawson R, Condos R, Tse D, Huie ML, Ress S, Tseng CH, Brauns C, Weiden M, Hoshino Y, Bateman E, Rom WN. Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. PLoS One. 2009 Sep 15;4(9):e6984. doi: 10.1371/journal.pone.0006984.
PubMed 19753300
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
- ClinicalTrials.gov ID
- NCT00201123
- Acronym / sponsor ID
- 264
- Conditions
- Tuberculosis, AIDS-related Complex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 10 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
Detailed description
BACKGROUND:
Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.
DESIGN NARRATIVE:
Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.
The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.
The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Placebo comparator | Other: PlaceboIsoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy |
| Aerosol Interferon-gamma | Experimental | Drug: Aerosol Interferon-GammaAerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide |
| Subcutaneous Interferon-Gamma | Experimental | Drug: Subcutaneous interferon-gammaSubcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
- Cluster of Differentiation 4 greater than 200 if HIV positive
- Ability to sign consent
- Bilateral, cavitary pulmonary TB
Key exclusion criteria (12 listed)
- Multidrug-resistant (MDR) TB
- Extrapulmonary TB
- HIV positive with opportunistic infection within 30 days of study entry
- Cancer
- Asthma
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 |
|---|---|---|
| Aerosol Interferon-GammaParticipants will receive aerosol interferon-gamma. | Drug | Aerosol Interferon-gamma |
| Subcutaneous interferon-gammaPatients will receive subcutaneous interferon-gamma | Drug | Subcutaneous Interferon-Gamma |
| Placebo | Other | Standard Treatment |
Primary outcome
Sputum Conversion
Time frame: Measured at 16 Weeks
2 secondary outcomes
Chest Cavity Size
Time frame: 16 Weeks
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Time frame: 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19753300Dawson R, Condos R, Tse D, Huie ML, Ress S, Tseng CH, Brauns C, Weiden M, Hoshino Y, Bateman E, Rom WN. Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. PLoS One. 2009 Sep 15;4(9):e6984. doi: 10.1371/journal.pone.0006984.
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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.
William Rom, MD, MPH principal investigator
NYU School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerosol Interferon-Gamma and Subcutaneous interferon-gamma in people with Tuberculosis and AIDS-related Complex, run by NYU Langone Health at 2 sites in 2 countries.
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 4 inclusion and 12 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 16 Dec 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 United States, South Africa. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sputum Conversion (time frame: Measured at 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201123, which also lists 1 linked publication.
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 16 Dec 2016.