Tuberculosis (TB) Immunotherapy Phase 2 Study

Lisichansk Regional Tuberculosis Dispensary40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Tuberculosis

Interventions

V7BIOLOGICAL

experimental arm

placeboOTHER

placebo pill

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lisichansk TB Dispensary

Lisichansk, Luhansk Oblast, Ukraine

Outcomes

Primary Outcomes

sputum conversion

To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:

Time frame: 2 months

Secondary Outcomes

safety

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.

Time frame: 1 and 2 months

Data from ClinicalTrials.gov

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