Tuberculosis (TB) Immunotherapy Phase 2 Study (imm02)

Lisichansk Regional Tuberculosis Dispensary

Status and phase

Completed

Phase 2

Conditions

Tuberculosis

Treatments

Other: placebo

Biological: V7

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01380119

LisichnskRTD (Other Identifier)

imm02

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.