[Evaluation of 2 tuberculosis chemoprophylaxis regimens in patients infected with human immunodeficiency virus. The GECMEI Group].
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.
Martínez Alfaro
E M
EM
Servicio de Medicina Interna, Hospitales Generales de Albacete.
Cuadra
F
F
Solera
J
J
Maciá
M A
MA
Geijo
P
P
Sánchez Martínez
P A
PA
Rodríguez Zapata
M
M
Largo
J
J
Sepúlveda
M A
MA
Rosa
C
C
Sánchez
L
L
Espinosa
A
A
Mateos
F
F
Blanch
J J
JJ
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*
D000904:Antibiotics, Antitubercular; D000995:Antitubercular Agents; D007538:Isoniazid; D012293:Rifampin