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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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 o
Sponsor: Lisichansk Regional Tuberculosis Dispensary

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • liver function [ Time Frame: 12 months ]
    To determine the safety of V5+ATT versus ATT+placebo in TB-infected subjects, Standard parameters, e.g., ALT and bilirubin, liver size will be measured.
  • quality of life [ Time Frame: 12 months ]
    Measure changes in quality of life by TB score questionnaire
  • hematology parameters [ Time Frame: 12 months ]
    Measure CBC by standard routine methods
  • weight gain [ Time Frame: 12 months ]
    Measure changes in body weight


Original Secondary Outcome: Same as current

Information By: Lisichansk Regional Tuberculosis Dispensary

Dates:
Date Received: June 30, 2010
Date Started: January 2010
Date Completion:
Last Updated: August 2, 2012
Last Verified: August 2012