drugset / Trial / NCT02654730
Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia
Phase 2/3
Terminated
61 enrolled
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with dihydroartemisinin-piperaquine in G6PD deficient males.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-09
- Completion
- 2016-12
Publications
- Background Eziefula AC, Pett H, Grignard L, Opus S, Kiggundu M, Kamya MR, Yeung S, Staedke SG, Bousema T, Drakeley C. Glucose-6-phosphate dehydrogenase status and risk of hemolysis in Plasmodium falciparum-infected African children receiving single-dose primaquine. Antimicrob Agents Chemother. 2014 Aug;58(8):4971-3. doi: 10.1128/AAC.02889-14. Epub 2014 Jun 9.
- Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Primaquine | Small molecule | 0.25 mg/kg | — |
| Subject | Primaquine | Small molecule | 0.4 mg/kg | — |
| Comparator | ARTENIMOL | Small molecule | 320 mg | Oral |
| Comparator | piperaquine | Small molecule | 40 mg | Oral |