Isoniazid preventive therapy for tuberculosis in HIV-1-infected adults
| Autor: | M.P. Hawken, John Porter, Job J. Bwayo, K. P. W. J. Mcadam, Francis A. Plummer, Elizabeth N. Ngugi, J. Kimari, L.N. Thiong'o, E S Juma, Charles F. Gilks, H Meme, Willie Githui, Paul Nunn, J.S. Morris, Joseph Odhiambo, Jeremiah Chakaya, L.C. Elliott |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Adult
Male medicine.medical_specialty Tuberculosis Adolescent Immunology Antitubercular Agents Tuberculin Placebo Rate ratio law.invention Double-Blind Method Randomized controlled trial law Internal medicine Isoniazid Humans Immunology and Allergy Medicine Aged Retrospective Studies AIDS-Related Opportunistic Infections business.industry Mortality rate bacterial infections and mycoses medicine.disease Survival Analysis Surgery Treatment Outcome Infectious Diseases Chemoprophylaxis Disease Progression Patient Compliance Female business Follow-Up Studies medicine.drug |
| Zdroj: | AIDS. 11:875-882 |
| ISSN: | 0269-9370 |
| DOI: | 10.1097/00002030-199707000-00006 |
| Popis: | Objectives To determine the efficacy of isoniazid 300 mg daily for 6 months in the prevention of tuberculosis in HIV-1-infected adults and to determine whether tuberculosis preventive therapy prolongs survival in HIV-1-infected adults. Design and setting Randomized, double-blind, placebo-controlled trial in Nairobi, Kenya. Subjects Six hundred and eighty-four HIV-1-infected adults. Main outcome measures Development of tuberculosis and death. Results Three hundred and forty-two subjects received isoniazid and 342 received placebo. The median CD4 lymphocyte counts at enrolment were 322 and 346 x 10(6)/l in the isoniazid and placebo groups, respectively. The overall median follow-up from enrolment was 1.83 years (range, 0-3.4 years). The incidence of tuberculosis in the isoniazid group was 4.29 per 100 person-years (PY) of observation [95% confidence interval (CI) 2.78-6.33] and 3.86 per 100 PY of observation (95% CI, 2.45-5.79) in the placebo group, giving an adjusted rate ratio for isoniazid versus placebo of 0.92 (95% CI, 0.49-1.71). The adjusted rate ratio for tuberculosis for isoniazid versus placebo for tuberculin skin test (TST)-positive subjects was 0.60 (95% CI, 0.23-1.60) and for the TST-negative subjects, 1.23 (95% CI, 0.55-2.76). The overall adjusted mortality rate ratio for isoniazid versus placebo was 1.18 (95% CI, 0.79-1.75). Stratifying by TST reactivity gave an adjusted mortality rate ratio in those who were TST-positive of 0.33 (95% CI, 0.09-1.23) and for TST-negative subjects, 1.39 (95% CI, 0.90-2.12). Conclusions Overall there was no statistically significant protective effect of daily isoniazid for 6 months in the prevention of tuberculosis. In the TST-positive subjects, where reactivation is likely to be the more important pathogenetic mechanism, there was some protection and some reduction in mortality, although this was not statistically significant. The small number of individuals in this subgroup made the power to detect a statistically significant difference in this subgroup low. Other influences that may have diluted the efficacy of isoniazid include a high rate of transmission of new infection and rapid progression to disease or insufficient duration of isoniazid in subjects with relatively advanced immunosuppression. The rate of drug resistance observed in subjects who received isoniazid and subsequently developed tuberculosis was low. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|