title: [Evaluation of 2 tuberculosis chemoprophylaxis regimens in patients infected with human immunodeficiency virus. The GECMEI Group].
abstract: OBJECTIVE
  To assess the compliance, tolerance and efficacy of a short chemoprophylaxis regimen (IR) for tuberculosis using isoniazid (INH) plus rifampin (RIF) during 3 months versus a standard regimen (I) of isoniazid during 12 months in HIV positive patients.
  
  
  METHODS
  Prospective, comparative, randomized and open clinical trial in four general hospitals and one prison hospital of Castilla-La Mancha. Prophylaxis was administered to PPD-positive patients and to anergic patients according to the CDC recommendations (1991). Patients were randomized in two treatment groups: regimen IR, isoniazid 300 mg daily and rifampin 600 mg daily; regimen I, isoniazid 300 mg during 12 months.
  
  
  RESULTS
  133 patients were included, 64 to regimen I and 69 to regimen IR. Regimen IR had a better tolerance with a 28% of adverse effects versus 55% in regimen I. Hepatotoxicity was more frequent in regimen I with a RR = 2.2 (CI 95% 1.23-4.01). Severe hepatotoxicity leading to treatment withdrawal was related to drug administration time and was more frequent in the 12 months regimen group. Short regimen showed a better compliance, without significant differences. Tuberculosis incidence rate was a 4.23 cases/100 persons--year for regimen I and 2.08 in regimen IR, with a relative risk for developing tuberculosis with regimen IR group of 0.51 (CI 95% 0.09-2.8) versus regimen I group, without statistical significance. Prison stay was associated to a significant risk for tuberculosis, regardless of both regimens (RR = 9.2 CI 95%, 1.06-80.2).
  
  
  CONCLUSIONS
  In HIV-infected patients with PPD(+) or anergic, regimen with IR is at least as effective as regimen I for preventing the development of tuberculous disease, and has less adverse effects.
authors.affiliation: Servicio de Medicina Interna, Hospitales Generales de Albacete.
authors.forename: E M
authors.initials: EM
authors.lastname: Martínez Alfaro
authors.forename: F
authors.initials: F
authors.lastname: Cuadra
authors.forename: J
authors.initials: J
authors.lastname: Solera
authors.forename: M A
authors.initials: MA
authors.lastname: Maciá
authors.forename: P
authors.initials: P
authors.lastname: Geijo
authors.forename: P A
authors.initials: PA
authors.lastname: Sánchez Martínez
authors.forename: M
authors.initials: M
authors.lastname: Rodríguez Zapata
authors.forename: J
authors.initials: J
authors.lastname: Largo
authors.forename: M A
authors.initials: MA
authors.lastname: Sepúlveda
authors.forename: C
authors.initials: C
authors.lastname: Rosa
authors.forename: L
authors.initials: L
authors.lastname: Sánchez
authors.forename: A
authors.initials: A
authors.lastname: Espinosa
authors.forename: F
authors.initials: F
authors.lastname: Mateos
authors.forename: J J
authors.initials: JJ
authors.lastname: Blanch
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D000328:Adult; D000904:Antibiotics, Antitubercular / Q000008:administration & dosage; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D015994:Incidence; D007538:Isoniazid / Q000008:administration & dosage / Q000009:adverse effects; D008099:Liver / Q000187:drug effects; D008297:Male; D011446:Prospective Studies; D012293:Rifampin / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D014374:Tuberculin Test; D014376:Tuberculosis / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000904:Antibiotics, Antitubercular; D000995:Antitubercular Agents; D007538:Isoniazid; D012293:Rifampin