NCT01222338 is a Phase 2 clinical trial of V-5 immunitor in Tuberculosis, sponsored by Lisichansk Regional Tuberculosis Dispensary.

Who is sponsoring NCT01222338?

NCT01222338 is sponsored by Lisichansk Regional Tuberculosis Dispensary.

What drugs are being tested in NCT01222338?

Interventions in NCT01222338: V-5 immunitor.

What condition does NCT01222338 study?

NCT01222338 studies Tuberculosis.

Is NCT01222338 still recruiting?

NCT01222338 is currently completed. Last updated 2 August 2012.

Last reviewed 2012-08-02 · How we verify

NCT01222338

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2 Placebo-controlled, Randomized Study of Oral Immunomodulator in TB and TB/HIV Patients

Completed Phase 2 Last updated 2 August 2012

What this trial tests

Phase 2 trial testing V-5 immunitor in Tuberculosis in 123 participants. Completed in 1 January 2011.

Timeline

1 January 2010

Primary endpoint
1 December 2010

1 January 2011

Quick facts

Lead sponsor	Lisichansk Regional Tuberculosis Dispensary
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	123
Start date	1 January 2010
Primary completion	1 December 2010
Estimated completion	1 January 2011
Sites	1 location across Ukraine

Drugs / interventions tested

V-5 immunitor — full drug profile →

Conditions studied

Tuberculosis — all drugs for Tuberculosis →

Sponsor

Lisichansk Regional Tuberculosis Dispensary — full company profile →

Who can join

Adults 18 to 70, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

primary endpoint: sputum smear conversion
Time frame: 12 months
Sputum smear conversion at monthly intervals timepoint Rates of pulmonary healing by chest X-ray at the end of study

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB.
Butov DA, Pashkov YN, Stepanenko AL, Choporova AI, et al · · 2011 · cited 12× · PMID 21244690 · DOI 10.1186/1476-8518-9-3

Verify or expand the search:

Other recruiting trials for Tuberculosis

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01222338 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lisichansk Regional Tuberculosis Dispensary
Last refreshed: 2 August 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01222338.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing