Phase 2
N=96
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Tuberculosis · AIDS-related Complex
Bottom Line
View on ClinicalTrials.gov: NCT00201123 ↗Enrolled (actual)
96
Serious AEs
7.9%
Results posted
Jun 2014
Primary outcome: Primary: Sputum Conversion — 36; 60; 36 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aerosol Interferon-Gamma (Drug); Subcutaneous interferon-gamma (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sputum Conversion |
36; 60; 36 | — |
| SECONDARY Chest Cavity Size |
34; 39; 34; 20; 29; 18 | — |
| SECONDARY Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels |
4; 5; 6; 15; 15; 22 | — |
Summary
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Multidrug-resistant (MDR) TB
- Extrapulmonary TB
- HIV positive with opportunistic infection within 30 days of study entry
- Cancer
- Asthma
- Pregnant or lactating women
- Chronic heart disease
- Chronic liver disease
- Chronic renal disease
- Seizure disorder
- Bleeding or clotting disorder
- Diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00201123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.