Jh. Perriens et al., PULMONARY TUBERCULOSIS IN HIV-INFECTED PATIENTS IN ZAIRE - A CONTROLLED TRIAL OF TREATMENT FOR EITHER 6 OR 12 MONTHS, The New England journal of medicine, 332(12), 1995, pp. 779-784
Background. We studied the efficacy of a short-course regimen of chemo
therapy for pulmonary tuberculosis in Kinshasa, Zaire. We also assesse
d whether, among patients with human immunodeficiency virus (HIV) infe
ction, treatment should be extended from 6 to 12 months. Methods. HIV-
seropositive and HIV-seronegative outpatients with pulmonary tuberculo
sis were treated with rifampin, isoniazid, pyrazinamide, and ethambuto
l daily for two months, followed by rifampin plus isoniazid twice week
ly for four months. The HIV-positive patients who had no evidence of t
uberculosis were then randomly assigned to receive either rifampin plu
s isoniazid or placebo twice weekly for a further six months. We also
followed a comparison group of HIV-seronegative patients who received
no further treatment for tuberculosis after six months. Results. After
six months, 260 of 335 HIV-seropositive and 186 of 188 HIV-seronegati
ve participants could be evaluated, and their rates of treatment failu
re were similar: 3.8 and 2.7 percent, respectively. At 24 months, the
HIV-seropositive patients who received extended treatment had a relaps
e rate of 1.9 percent, as compared with 9 percent among the HIV-seropo
sitive patients who received placebo for the second 6 months (P<0.01).
Extended treatment did not improve survival, however. Among the HIV-s
eronegative patients, 5.3 percent relapsed. Conclusions. Among HIV-ser
opositive patients with pulmonary tuberculosis, extending treatment fr
om 6 to 12 months reduces the rate of relapse but does not improve sur
vival. The six-month program of partly intermittent antituberculous tr
eatment may be an acceptable alternative when resources are limited.