[Randomized clinical trial investigating three chemoprophylaxis regimens for latent tuberculosis infection in HIV-infected patients].
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 Twenty-seven percent of patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects or interactions. Seven patients were withdrawn due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ).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.
Rivero
Antonio
A
Sección de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Córdoba, España. ariveror@saludalia.com
López-Cortés
Luis
L
Castillo
Rafael
R
Verdejo
José
J
García
Miguel Angel
MA
Martínez-Marcos
Francisco Javier
FJ
Díez
Felipe
F
Escribano
José Carlos
JC
Canueto
Jesús
J
Lozano
Fernando
F
Pasquau
Juan
J
Hernández
Juan José
JJ
Márquez
Manuel
M
Kindelán
José María
JM
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
D000995:Antitubercular Agents; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin