A clinical trial with halofantrine on patients with falciparum malaria in Colombia.
A total of 120 semi-immune adult male malaria patients from an area of multidrug-resistant Plasmodium falciparum malaria were hospitalized for 42 days in Medellin, Colombia (an area of no malaria transmission), and treated with halofantrine in a double-blind, randomized, prospective clinical trial according to five different treatment schedules. Each patient was assigned to one of the following halofantrine schedules: I, one dose of 1000 mg; II, three doses of 500 mg; III, two doses of 500 mg; IV, three doses of 250 mg; and V, one dose of 750 mg. Best results (75% cure rate) were obtained with schedule II, although there was no statistically significant difference compared with the other schedules. A total of 46 patients experienced recrudescent malaria. Drug levels in plasma 72 hours after beginning treatment showed no statistically significant difference between relapsing and cured patients. Side-effects (mainly gastrointestinal) were uncommon and mild. Cardiotoxicity was studied by electrocardiogram. A mean prolongation of 28.5 ms (6.6 +/- 6.3% increase from baseline) was observed in the Q-Tc interval on day 1 of the trial.
Restrepo
M
M
Instituto Colombiano de Medecina Tropical, Medellin, Colombia.
Botero
D
D
Marquez
R E
RE
Boudreau
E F
EF
Navaratnam
V
V
D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003105:Colombia; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006321:Heart / Q000187:drug effects; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010616:Phenanthrenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence
D000962:Antimalarials; D010616:Phenanthrenes; C023768:halofantrine