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A phase I clinical trial of Fansimef (mefloquine plus sulfadoxine-pyrimethamine) in Brazilian male subjects.
Bull World Health Organ. 1985; 63(3):611-5.BW

Abstract

A double-blind, randomized phase I clinical trial was carried out to compare Fansimef (a fixed-dose combination of mefloquine, sulfadoxine, and pyrimethamine) with sulfadoxine and pyrimethamine (Fansidar) for safety and tolerance. Twenty adult male Brazilian subjects from malaria endemic areas were studied for a period of 66 days, which included 2 days before and 63 days after drug administration.Both drugs were well tolerated and safe, as seen from the absence of drug-induced changes in the various laboratory, haematological, and biochemical parameters measured. Fansimef produced a complete clearance of parasites on day 3, with an "S" type response in one subject who had blood smears which were positive for Plasmodium falciparum on day 0. Two subjects in the sufladoxine-pyrimethamine group also had P. falciparum infections on day 0; the parasitaemia was cleared on day 2 in one of these subjects and on day 3 in the other, but an early RI response (recrudescence) was observed in the former case. Relapses due to P. vivax occurred in both groups.Side-effects due to Fansimef included mild dizziness, nausea, and vomiting. The incidence of dizziness and nausea was similar in the sulfadoxine-pyrimethamine group. In both groups, these side-effects were mild, short-lived and did not require specific treatment. Thus, Fansimef in an oral dose of three tablets (total of 750 mg mefloquine (base) plus 1500 mg sulfadoxine plus 75 mg pyrimethamine) was found to be well tolerated and safe.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

3899398

Citation

de Souza, J M., et al. "A Phase I Clinical Trial of Fansimef (mefloquine Plus Sulfadoxine-pyrimethamine) in Brazilian Male Subjects." Bulletin of the World Health Organization, vol. 63, no. 3, 1985, pp. 611-5.
de Souza JM, Sheth UK, de Oliveira RM, et al. A phase I clinical trial of Fansimef (mefloquine plus sulfadoxine-pyrimethamine) in Brazilian male subjects. Bull World Health Organ. 1985;63(3):611-5.
de Souza, J. M., Sheth, U. K., de Oliveira, R. M., Gomes, A. T., & Cavalcante, E. Q. (1985). A phase I clinical trial of Fansimef (mefloquine plus sulfadoxine-pyrimethamine) in Brazilian male subjects. Bulletin of the World Health Organization, 63(3), 611-5.
de Souza JM, et al. A Phase I Clinical Trial of Fansimef (mefloquine Plus Sulfadoxine-pyrimethamine) in Brazilian Male Subjects. Bull World Health Organ. 1985;63(3):611-5. PubMed PMID: 3899398.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase I clinical trial of Fansimef (mefloquine plus sulfadoxine-pyrimethamine) in Brazilian male subjects. AU - de Souza,J M, AU - Sheth,U K, AU - de Oliveira,R M, AU - Gomes,A T, AU - Cavalcante,E Q, PY - 1985/1/1/pubmed PY - 1985/1/1/medline PY - 1985/1/1/entrez SP - 611 EP - 5 JF - Bulletin of the World Health Organization JO - Bull World Health Organ VL - 63 IS - 3 N2 - A double-blind, randomized phase I clinical trial was carried out to compare Fansimef (a fixed-dose combination of mefloquine, sulfadoxine, and pyrimethamine) with sulfadoxine and pyrimethamine (Fansidar) for safety and tolerance. Twenty adult male Brazilian subjects from malaria endemic areas were studied for a period of 66 days, which included 2 days before and 63 days after drug administration.Both drugs were well tolerated and safe, as seen from the absence of drug-induced changes in the various laboratory, haematological, and biochemical parameters measured. Fansimef produced a complete clearance of parasites on day 3, with an "S" type response in one subject who had blood smears which were positive for Plasmodium falciparum on day 0. Two subjects in the sufladoxine-pyrimethamine group also had P. falciparum infections on day 0; the parasitaemia was cleared on day 2 in one of these subjects and on day 3 in the other, but an early RI response (recrudescence) was observed in the former case. Relapses due to P. vivax occurred in both groups.Side-effects due to Fansimef included mild dizziness, nausea, and vomiting. The incidence of dizziness and nausea was similar in the sulfadoxine-pyrimethamine group. In both groups, these side-effects were mild, short-lived and did not require specific treatment. Thus, Fansimef in an oral dose of three tablets (total of 750 mg mefloquine (base) plus 1500 mg sulfadoxine plus 75 mg pyrimethamine) was found to be well tolerated and safe. SN - 0042-9686 UR - https://www.unboundmedicine.com/medline/citation/3899398/A_phase_I_clinical_trial_of_Fansimef__mefloquine_plus_sulfadoxine_pyrimethamine__in_Brazilian_male_subjects_ DB - PRIME DP - Unbound Medicine ER -