Phase2a Primaquine Dose Escalation Study

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; Mahidol Oxford Tropical Medicine Research Unit; Malaria Research and Training Center, Bamako, Mali; Shoklo Malaria Research Unit; Shoklo Malaria Research, Tak, Thailand; Wellcome Trust
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Primaquine

Criteria

Inclusion Criteria:

• Male

• Age >= 18 years and < 50 years

• Malaria blood thick film positive

• Presence of gametocytes on thick blood film

• Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits

• No allergies to study drugs

• Hemoglobin >= 8 g/dl

• No evidence of severe or chronic disease

• Written, informed consent