Mycobacterium vaccae (SRL172) immunotherapy as an adjunct to standard antituberculosis treatment in HIV-infected adults with pulmonary tuberculosis: a randomised placebo-controlled trial


Mwinga, A; Nunn, A; Ngwira, B; Chintu, C; Warndorff, D; Fine, P; Darbyshire, J; Zumla, A; (2002) Mycobacterium vaccae (SRL172) immunotherapy as an adjunct to standard antituberculosis treatment in HIV-infected adults with pulmonary tuberculosis: a randomised placebo-controlled trial. Lancet, 360 (9339). pp. 1050-5. ISSN 0140-6736 DOI: 10.1016/S0140-6736(02)11141-X

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Abstract

BACKGROUND: Mortality rates of HIV-infected patients treated for tuberculosis remain high. This study aimed to assess the effect on mortality of immunotherapy with single-dose SRL172 added to standard antituberculosis chemotherapy in such patients. METHODS: The double-blind trial enrolled 1229 patients aged 18-60 years, who had never received antiretroviral treatment and who presented with newly diagnosed, sputum-smear-positive pulmonary tuberculosis to referral centres in Lusaka, Zambia, and Karonga, Malawi. Both HIV-positive and HIV-negative patients were enrolled, to avoid stigmatisation. Participants were randomly assigned a single injection of SRL172 or matching placebo within 2 weeks of starting 8 months of antituberculosis chemotherapy and followed up for at least 12 months. The primary endpoint was time to death in the HIV-infected population. Analyses were based on 760 HIV-positive patients after exclusion of 84 patients with errors in storage of the injection, no bacteriological confirmation, or no HIV result. FINDINGS: Of 760 HIV-infected patients, 374 received SRL172 and 386 received placebo. SRL172 did not cause any serious adverse events. The follow-up rate was 88% at 12 months in both groups. Of the HIV-positive patients, 109 (19.5 per 100 person-years) of 372 assigned SRL172 and 107 (19.3 per 100 person-years) of 386 assigned placebo died. In the Cox's regression analysis, stratified by centre, the hazard ratio of deaths (SRL172/placebo) was 1.03 (95% CI 0.79-1.35). There was no evidence of benefit to the group assigned SRL172. INTERPRETATION: Immunotherapy with single-dose SRL172 as an adjunct to standard antituberculosis treatment in HIV-positive adults with pulmonary tuberculosis had no significant effect on survival or bacteriological outcome, though the treatment was safe and well tolerated.

Item Type: Article
Keywords: Human-immunodeficiency-virus, 3-dose series, united-states, immunization, healthy, AIDS-Related Opportunistic Infections, diagnosis, drug therapy, microbiology, mortality, Adjuvants, Immunologic, therapeutic use, Adult, Antitubercular Agents, therapeutic use, Bacterial Vaccines, therapeutic use, Double-Blind Method, Female, Follow-Up Studies, Human, Immunotherapy, methods, Injections, Intradermal, Malawi, epidemiology, Male, Placebos, Proportional Hazards Models, Sputum, microbiology, Support, Non-U.S. Gov't, Survival Analysis, Treatment Outcome, Tuberculosis, Pulmonary, diagnosis, drug therapy, microbiology, mortality, Zambia, epidemiology
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: TB Centre
Vaccine Centre
MEIRU
PubMed ID: 12383985
Web of Science ID: 178485200010
URI: http://researchonline.lshtm.ac.uk/id/eprint/16291

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