Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The first-diagnosed Mycobacterium tuberculosis infection (TB) is curable with the first line
      of anti-tuberculosis drugs (ATT) in over 90% of cases within 6 months. The treatment of TB,
      refractory to conventional ATT, requires the deployment of second line TB drugs. This
      represents a significant challenge, particularly in resource-poor countries.

      The incidence of TB in Ukraine prior to 1992 was about 40 cases per 100,000 people. Ten years
      later, TB cases increased to over 80/100,000, with mortality doubled from 10.2/100,000 to
      21.6/100,000. Drug-resistant TB is now common in Ukraine. Isoniazid and rifampicin
      resistance, which defines the MDR-TB, has been found in 44% and 32.9% of TB isolates. The
      first Ukrainian case of HIV was reported in 1987. Today, Ukraine has the highest HIV rate in
      the Eastern Europe, with increasing proportion of dual infection. For example, in 2002 the
      prevalence of TB and HIV co-infection was 6.3%, but in 2006 at least 15.5 % of TB patients
      had HIV co-infection.

      It is clear that alternative and improved treatment options are needed. If such an
      intervention is found, the impact on the healthcare and clinical management of
      treatment-refractory TB and TB-HIV patients will be tremendous. The significant efforts are
      directed at finding new drugs and vaccines against TB. Immune-based interventions are
      actively sought as an adjunct therapy to conventional ATT. In earlier study the investigators
      have accidentally observed that when patients with chronic hepatitis C and HIV-TB were given
      V5 together with TB drugs it resulted in negative sputum conversion in 95% of patients within
      one month. This startling finding had prompted this study. The aim of the present study is to
      compare the clinical benefit of TB therapy in combination with V5 versus combination of
      placebo with ATT in a representative population of patients who are poorly manageable due to
      relapsing TB, MDR-TB, or TB-HIV co-infection.
    

Intervention name(s): V-5 immunitor
Intervention type(s): Biological
Intervention description(s): once per day dosing for 2 months
Other intervention name(s): V5, V-5 immunitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mycobacterium; MDR-TB; XDR-TB; HIV; HCV