MedTrace Logo

Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients

NCT01222338 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2012-08-03

No results posted yet for this study

Summary

Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24 months) and more toxic treatment course. In prior open label study the investigators have shown that adding V-5 Immunitor (V5), can reduce treatment duration to one month and enhance by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators propose to conduct placebo-controlled clinical trial in patients with treatment refractory TB so that the clinical benefit of V5 is confirmed.

Conditions

Interventions

BIOLOGICAL

V-5 immunitor

once per day dosing for 2 months

Sponsors & Collaborators

  • National Medical University, Ukraine

    collaborator OTHER

  • Immunitor USA Inc.

    collaborator INDUSTRY

  • Lisichansk Regional Tuberculosis Dispensary

    lead OTHER

Principal Investigators

  • Dmytro Butov, MD · Kharkiv National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222338 on ClinicalTrials.gov