A phase II clinical trial of mefloquine in Brazilian male subjects.
Mefloquine was compared with sulfadoxine-pyrimethamine for safety and efficacy in a randomized, double-blind clinical trial in adult males from a malaria-endemic area of Brazil. A total of 99 oligosymptomatic and symptomatic volunteers with Plasmodium falciparum parasitaemia took part in the trial; 49 were given 1000 mg of mefloquine and the remainder received 1500 mg of sulfadoxine plus 75 mg of pyrimethamine, in a single oral dose.Mefloquine was 100% successful in clearing parasitaemia within 7 days; there were no recrudescences. Sulfadoxine-pyrimethamine was less successful; 35 cases showed an S-type response, 8 an RI response, 3 an RII, and 2 an RIII response. The side-effects of mefloquine were mild and transient and included headache, nausea, vomiting, dizziness, and diarrhoea. A satisfactory weight gain and rise in haemoglobin level were seen in both groups.
D000328:Adult; D000962:Antimalarials / Q000627:therapeutic use*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D008297:Male; D015767:Mefloquine; D010963:Plasmodium falciparum; D011739:Pyrimethamine / Q000008:administration & dosage; D011804:Quinolines / Q000627:therapeutic use*; D011897:Random Allocation; D013413:Sulfadoxine / Q000008:administration & dosage
D000962:Antimalarials; D011804:Quinolines; D013413:Sulfadoxine; D015767:Mefloquine; D011739:Pyrimethamine