Trials / Completed
CompletedNCT02174900
Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)
Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- London School of Hygiene and Tropical Medicine · Academic / Other
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine | |
| DRUG | Artemether-Lumefantrine (AL) combination | |
| DRUG | Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-06-26
- Last updated
- 2016-02-01
Locations
1 site across 1 country: Burkina Faso
Source: ClinicalTrials.gov record NCT02174900. Inclusion in this directory is not an endorsement.