Overview

This trial is active, not recruiting.

Condition tuberculosis
Treatments v7, placebo
Phase phase 3
Sponsor Lisichansk Regional Tuberculosis Dispensary
Collaborator National Medical University, Ukraine
Start date March 2015
End date October 2016
Trial size 440 participants
Trial identifier NCT01977768, imm03

Summary

The purpose of the study is to identify optimally effective dose of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill and consequently carry out multi-country, placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
Daily pill of V7 together with standard tuberculosis therapy
v7 V7 or tableted heat-inactivated mycobacterium vaccae
One pill of V7 once daily for 30 days together with standard of care TB drugs
(Placebo Comparator)
one pill of placebo pill once per day together with standard of care TB drugs
placebo

Primary Outcomes

Measure
bacillary sputum smear clearance
time frame: two years

Secondary Outcomes

Measure
changes in body weight
time frame: 2 years
changes in inflammation markers
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - confirmed diagnosis of TB - sputum smear positive Exclusion Criteria: - pregnant - likely to be non-compliant due to drug and/or alcohol abuse - mentally unfit to comply with treatment

Additional Information

Official title Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)
Principal investigator Aldar Bourinbaiar, PhD, MD/PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Lisichansk Regional Tuberculosis Dispensary.