The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.
Main end-point is negative sputum conversion rate after one month in patients on V7 vs placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of 1st and/or 2nd line TB drugs according to baseline diagnosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
Misheel Lung surgery hospital,
Ulaanbaatar, Ulaanbaatar, Mongolia
Lisichansk Regional TB Dispensary
Lysychansk, Ukraine
bacillary sputum smear clearance
blinded assessment of sputum clearance score
Time frame: two years
changes in body weight
comparison of body weight between treatment arm and placebo
Time frame: 2 years
changes in body mass index (BMI)
comparison of body mass index (BMI) between treatment arm and placebo
Time frame: 2 years
changes in inflammation markers
changes in erythrocyte sedimentation (ERS) rate and leukocyte counts
Time frame: 2 years
changes in liver function test
changes in ALT, AST and total bilirubin levels
Time frame: 2 years
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