CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Aerosol Interferon-Gamma +2 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
  • ✓CD4 count greater than 200 if HIV positive
  • ✓Bilateral, cavitary pulmonary TB
Key exclusion· 12
  • ✕Multidrug-resistant (MDR) TB
  • ✕Extrapulmonary TB
  • ✕HIV positive with opportunistic infection within 30 days of study entry
  • ✕Cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00201123
NCT00201123Phase 2Completed
CompareCT.gov

Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome

NYU Langone Health·interventional·Posted Sep 20, 2005·Updated Dec 16, 2016

In Brief

A Phase 2 clinical trial evaluating Aerosol Interferon-Gamma, Subcutaneous interferon-gamma, and 1 other intervention for Tuberculosis and AIDS-related Complex. Completed, enrolled 89 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, AIDS-related Complex
CountriesSouth Africa, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartApr 1, 2005
Primary CompletionJan 1, 2007
Study CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.8 years ago

Interventions

Aerosol Interferon-Gammadrug

Participants will receive aerosol interferon-gamma.

Subcutaneous interferon-gammadrug

Patients will receive subcutaneous interferon-gamma

Placeboother