[Randomized trial of three regimens to prevent tuberculosis in HIV-infected patients with anergy].
BACKGROUND
To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy.


METHODS
Prospective, multi-center, randomized, comparative, and open clinical trial. Anergy was defined as absence of induration in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the Mantoux method. Patients were randomized into one of the following prophylactic treatment groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH), rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of treatment, patients were followed up for two years.


RESULTS
A total of 319 patients were included in the study, 83 in the 6H regimen, 82 in 3RH, 77 in 2RZ and 77 in NT. The observation period following treatment was 88, 96, 81 and 126 person-years, respectively, for 6H, 3RH, 2RZ and NT. There were 11 cases of tuberculosis during the follow-up period. The tuberculosis rates (cases per 100 person-years) were 3.4, 3.1, 1.2 and 3.1 for 6H, 3RH, 2RZ and NT respectively, with relative risks in regimens 6H, 3RH and 2RZ with respect to NT of 1.07 (0.24-4.80), 0.98 (0.22-4.4) and 0.39 (0.04-3.48), all statistically non-significant. Twenty-nine patients died during the follow-up period, none due to tuberculosis, and no appreciable differences were found among the groups.


CONCLUSIONS
The results showed no significant decrease in the risk of developing tuberculosis with any of the evaluated regimens and, therefore, do not support the use of antituberculosis chemoprophylaxis in anergic HIV-infected patients.
Rivero
Antonio
A
Servicios de Enfermedades Infecciosas. Hospital Virgen de la Victoria. Málaga. España. arivero@hrs.sas.junta-andalucia.es
López-Cortés
Luis
L
Castillo
Rafael
R
Lozano
Fernando
F
García
Miguel Angel
MA
Díez
Felipe
F
Escribano
José Carlos
JC
Canueto
Jesús
J
Pasquau
Juan
J
Hernández
Juan José
JJ
Polo
Rosa
R
Martínez-Marcos
Francisco Javier
FJ
Kindelán
José María
JM
Rey
Rafael
R
D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D011446:Prospective Studies; D011718:Pyrazinamide / Q000008:administration & dosage / Q000627:therapeutic use; D012293:Rifampin / Q000008:administration & dosage / Q000627:therapeutic use; D012306:Risk; D012307:Risk Factors; D017211:Treatment Failure; D014376:Tuberculosis / Q000517:prevention & control*
D000995:Antitubercular Agents; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin