title: [Randomized clinical trial investigating three chemoprophylaxis regimens for latent tuberculosis infection in HIV-infected patients].
abstract: OBJECTIVE
  To evaluate the adherence to, and safety of three chemoprophylaxis regimens for latent tuberculosis (TB) infection in HIV-infected patients with a positive tuberculin skin test.
  
  
  METHODS
  A randomized, comparative, open clinical assay was carried out in 316 HIV-infected patients in 12 Spanish hospitals. Patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to rifampin and pyrazinamide for two months (2RZ). After completion of treatment, patients were followed-up for two years.
  
  
  RESULTS
  The period of observation following completion of treatment was 115, 108 and 101 person-years for 6H, 3RH and 2RZ, respectively. Twenty-seven percent of patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects or interactions. Seven patients were withdrawn due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens. There were 11 cases of tuberculosis during follow-up. The TB rates (cases per 100 person-years) in the three treatment groups were 3.48 in 6H, 4.63 in 3RH and 1.98 in 2RZ. With respect to 2RZ, the relative risk for TB in the 6H and 3RH regimens was 1.76 and 2.34, respectively.
  
  
  CONCLUSIONS
  The safety of the 2RZ regimen for prophylaxis of latent TB infection in HIV patients was similar to that of the 6H and 3RH regimens. The incidence of hepatotoxicity was not higher in patients who received 2RZ.
authors.affiliation: Sección de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Córdoba, España. ariveror@saludalia.com
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
authors.forename: Luis
authors.initials: L
authors.lastname: López-Cortés
authors.forename: Rafael
authors.initials: R
authors.lastname: Castillo
authors.forename: José
authors.initials: J
authors.lastname: Verdejo
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: García
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Martínez-Marcos
authors.forename: Felipe
authors.initials: F
authors.lastname: Díez
authors.forename: José Carlos
authors.initials: JC
authors.lastname: Escribano
authors.forename: Jesús
authors.initials: J
authors.lastname: Canueto
authors.forename: Fernando
authors.initials: F
authors.lastname: Lozano
authors.forename: Juan
authors.initials: J
authors.lastname: Pasquau
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Hernández
authors.forename: Manuel
authors.initials: M
authors.lastname: Márquez
authors.forename: José María
authors.initials: JM
authors.lastname: Kindelán
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use; D008297:Male; D009169:Mycobacterium tuberculosis / Q000502:physiology; D011718:Pyrazinamide / Q000627:therapeutic use; D012293:Rifampin / Q000627:therapeutic use; D014376:Tuberculosis / Q000150:complications* / Q000517:prevention & control*; D017735:Virus Latency
chemical_list: D000995:Antitubercular Agents; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin