Tuberculosis
Conditions
Keywords
sputum conversion, liver biochemistry, weight loss, quality of life
Brief summary
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.
Interventions
BIOLOGICALV7
experimental arm
OTHERplacebo
placebo pill
Sponsors
National Medical University, Ukraine
Immunitor USA Inc.
Lisichansk Regional Tuberculosis Dispensary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included. * TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test. * TB score status at baseline. * Agreement to participate in the study and to give a sample of blood for lab testing. * Readily available home or other address where patient can be found.
Exclusion criteria
* Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded. * Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry. * Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sputum conversion | 2 months | To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including: |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety | 1 and 2 months | 1. Liver functions tests (AST and ALT, and bilirubin) as main biochemical tests 2. To confirm quality of life improvement by specially designed questionnaire TB score 3. The beneficial effect on TB-associated wasting by measuring body weight. |
Countries
Ukraine
Outcome results
None listed