Thrice-weekly sulfadiazine-pyrimethamine for maintenance therapy of toxoplasmic encephalitis in HIV-infected patients. Spanish Toxoplasmosis Study Group.
An open, randomised, multicentre trial was conducted to evaluate the efficacy of thrice-weekly versus daily therapy with sulfadiazine-pyrimethamine in the prevention of relapses of toxoplasmic encephalitis in HIV-infected patients. Between February 1994 and July 1997, 124 patients with HIV infection were enrolled after resolution of the first acute episode of toxoplasmic encephalitis treated with sulfadiazine-pyrimethamine. Patients were randomly assigned to receive either a daily regimen consisting of sulfadiazine (1 g) twice a day plus 25 mg pyrimethamine and 15 mg folinic acid daily (n = 58), or a thrice-weekly regimen consisting of the same doses of sulfadiazine and folinic acid plus 50 mg pyrimethamine (n = 66). After a median follow-up period of 11 months (range 1-39 months), no differences were found in the incidence of toxoplasmic encephalitis relapses between the groups, there being 14.9 episodes per 100 patient-years (95% CI: 2.8-20.2) in the daily-regimen group versus 14.1 episodes (95% CI: 2.3-17.2) in the intermittent-regimen group. The estimated cumulative percentages of relapse at 12 months were 17% and 19%, respectively (P = 0.91). In a Cox multivariate analysis, not taking antiretroviral therapy was the only variable independently associated with relapse (adjusted risk ratio: 4.08; 95%CI: 1.32-12.66). Baseline CD4+ cell counts, prior AIDS, mental status, sequelae and allocated maintenance therapy regimen were not independent predictors of relapse. No differences were observed in the survival rate (P = 0.42), or in the incidence of severe adverse effects (P = 0.79). The efficacy of the thrice-weekly regimen was similar to that of the daily regimen in the prevention of relapses of toxoplasmic encephalitis. Administration of antiretroviral therapy was the only factor associated with a lower incidence of relapse.
Podzamczer
D
D
Infectious Disease Service, Ciutat Sanitària de Bellvitge, c/Feixa Llarga s/n. L'Hospitalet, Barcelona, Spain. dpodzamczer@csub.scs.es
Miró
J M
JM
Ferrer
E
E
Gatell
J M
JM
Ramón
J M
JM
Ribera
E
E
Sirera
G
G
Cruceta
A
A
Knobel
H
H
Domingo
P
P
Polo
R
R
Leyes
M
M
Cosin
J
J
Fariñas
M C
MC
Arrizabalaga
J
J
Martínez-Lacasa
J
J
Gudiol
F
F
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000469:parasitology; D000328:Adult; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004660:Encephalitis / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D011739:Pyrimethamine / Q000008:administration & dosage / Q000627:therapeutic use*; D013411:Sulfadiazine / Q000008:administration & dosage / Q000627:therapeutic use*; D016781:Toxoplasmosis, Cerebral / Q000188:drug therapy*; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; D013411:Sulfadiazine; D011739:Pyrimethamine