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

NCT01222338 | Completed Phase 2 DMC

• 1 other identifier: imm01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis

Keywords

Mycobacterium; MDR-TB; XDR-TB; HIV; HCV

Outcome Measures

Primary Outcomes (1)

• primary endpoint: sputum smear conversion

  Sputum smear conversion at monthly intervals timepoint Rates of pulmonary healing by chest X-ray at the end of study

  12 months

Secondary Outcomes (4)

• liver function

  12 months

• quality of life

  12 months

• hematology parameters

  12 months

• weight gain

  12 months

Study Arms (2)

Immunomodulator intervention

ACTIVE COMPARATOR

Two cohorts or arms of at least 60 subjects each (total 120) with pulmonary TB positive for sputum AFB smear will be randomized in a 1:1 ratio to receive once-daily, tablet of V-5 immunitor in combination with standard ATT for 2 months followed by ATT outside of trial for next 4 months or however long it needs to be.

Biological: V-5 immunitor

placebo

PLACEBO COMPARATOR

Control Cohort 1 (60 subjects) will receive standard first-line ATT regimen: (daily Isoniazide (H) 150mg, Rifampicin (R) 300mg, Ethambutol (E) 400mg, and Pyrazinamide (Z) 400mg during first 2 months, followed by H/R three times per week for the next 4 months. Patients also will receive placebo preparation, appearing identical to V-5 immunitor, taken once daily 30 minutes prior or after meal for 2 months

Biological: V-5 immunitor

Interventions

V-5 immunitor BIOLOGICAL

once per day dosing for 2 months

Also known as: V5, V-5 immunitor

Immunomodulator intervention; placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are at least 18 years old and are willing and capable of providing written-informed consent.
• Both men and non-pregnant women will be included.
• One group of 30 patients will have HIV.
• Another group of 30 patients will have drug-resistant TB (MDR or XDR).
• Remaining 60 patients will have drug-sensitive TB of which 30 will be assigned to placebo.
• TB infection documented prior to Study Entry by either the presence of TB rapid test or sputum smear positive for acid-fast bacilli (AFB).
• At least two independent tests are sought to confirm TB diagnosis.
• Agreement to participate in the study and to give a sample of blood for HIV testing.

You may not qualify if:

• Subjects who have already taken V5 in prior trial and those without baseline data.
• Those who are re-treated and relapsed will be eligible as long as they are on the same drug regimen as the rest of patients.
• Pregnant or breast-feeding women are excluded.
• Subjects who have taken anti-retroviral drugs or immunomodulatory therapies within 2 months prior to Entry:
• systemic corticosteroids
• immune globulin (IV gamma globulin, IVIG)
• interferons,
• interleukins
• pentoxifylline (Trental)
• thalidomide
• filgrastim (G-CSF)
• sargramostim (GM-CSF)
• dinitrochlorobenzene (DNCB)
• thymosin alpha 1 (thymosin alpha)
• thymopentin

Sponsors & Collaborators

• Lisichansk Regional Tuberculosis Dispensary: lead
• National Medical University, Ukraine: collaborator
• Immunitor USA Inc.: collaborator

Study Sites (1)

Lisichansk TB Dispensary

Lisichansk, Luhansk Oblast, 20001, Ukraine

Location

Related Publications (3)

• DOI 10.2217/imt.12.59

  RESULT

• Batbold U, Butov DO, Kutsyna GA, Damdinpurev N, Grinishina EA, Mijiddorj O, Kovolev ME, Baasanjav K, Butova TS, Sandagdorj M, Batbold O, Tseveendorj A, Chunt E, Zaitzeva SI, Stepanenko HL, Makeeva NI, Mospan IV, Pylypchuk VS, Rowe JL, Nyasulu P, Jirathitikal V, Bain AI, Tarakanovskaya MG, Bourinbaiar AS. Double-blind, placebo-controlled, 1:1 randomized Phase III clinical trial of Immunoxel honey lozenges as an adjunct immunotherapy in 269 patients with pulmonary tuberculosis. Immunotherapy. 2017 Jan;9(1):13-24. doi: 10.2217/imt-2016-0079. Epub 2016 Nov 21.

  PMID: 27868466 DERIVED

• Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Batdelger D, Jirathitikal V, Bourinbaiar AS. Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB. Immunotherapy. 2011 Feb;3(2):181-91. doi: 10.2217/imt.10.96. Epub 2010 Dec 24.

  PMID: 21182457 DERIVED

Related Links

• Phase 2 trial of V-5 Immunitor (V5) in patients with chronic hepatitis C co-infected with HIV and Mycobacterium tuberculosis
• doi: 10.4172/2161-1068.S1-001 Therapeutic Vaccination of Treatment-Failed TB Patients on "Palliative" Support Consisting of Isoniazid and Rifampicin
• Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB.
• Immune approaches in tuberculosis therapy: a brief overview.

MeSH Terms

Conditions

Tuberculosis; Mycobacterium Infections; Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis

Interventions

V-5 immunitor

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Dmytro Butov, MD

  Kharkiv National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: October 18, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

UA (1)