Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis.

Immunoxel (Dzherelo) is an oral, herbal immunomodulator used in Ukraine for adjunct therapy of infectious and autoimmune diseases. Antiretroviral drug-naive, tuberculosis (TB)/HIV coinfected patients with active pulmonary TB were divided into two arms, A (n = 20) and B (n = 20), to receive first-line anti-TB therapy (ATT) or ATT + Dzherelo, respectively. As a result, three (16%) versus 12 (67%; p = 0.003) patients had Mycobacterium tuberculosis culture conversion, with time to negative culture of 6 and 4 months in arms A and B, respectively. In the ATT-alone arm, the healing of pulmonary cavitations was observed in 25% of patients at weeks 24-28, while 60% of individuals in arm B healed at 16-18 weeks (p = 0.025). The TB lesions, on chest x-ray, had cleared in 46 and 84%, with time-to-clearance of 24-28 and 16-18 weeks in arms A and B, respectively. In the ATT-alone arm, the bodyweight at baseline was 64 +/- 6.3 kg, with 13 cachexic patients who had an average weight deficit of -5.2 +/- 1.7 kg. At the end of 6 months of follow-up, they have lost an additional 0.6 kg (-5.8 +/- 2.4). The study entry-level weight in arm B was 52 +/- 5.7 kg, with 12 individuals who had a body mass deficit of -8.5 +/- 2.7 kg. The immunotherapeutic intervention increased bodyweight by an average of 5.8 +/- 2.6 kg above baseline (p < 0.0001). The inclusion of Dzherelo into the ATT regimen decreased the incidence of new opportunistic infections (OI) with three episodes of OI versus 12 in arm A (p = 0.003). These findings indicate that Dzherelo contributes positively to the clinical efficacy of TB drugs.

RCT Entities:   Population Interventions Outcomes