Phase2a Primaquine Dose Escalation Study

Phase 2

Completed

• Conditions: Malaria
• Interventions: Drug: dihydroartemisinin-piperaquine; Drug: 0.0625 mg/kg Primaquine; Drug: 0.25 mg/kg Primaquine; Drug: 0.125 mg/kg Primaquine; Drug: 0.5 mg/kg Primaquine

• Registration Number: NCT01743820
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Study Start: 2013-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 81

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DP and 0.0625 mg/kg primaquine	0.0625 mg/kg Primaquine	DP and a single dose oral 0.0625 mg/kg primaquine
dihydroartemisinin-piperaquine only	dihydroartemisinin-piperaquine	dihydroartemisinin -piperaquine (DP) only
DP and 0.125 mg/kg primaquine	dihydroartemisinin-piperaquine	DP and single dose oral 0.125 mg/kg primaquine
DP and 0.5 mg/kg primaquine	dihydroartemisinin-piperaquine	DP and single dose oral 0.5 mg/kg primaquine
DP and 0.0625 mg/kg primaquine	dihydroartemisinin-piperaquine	DP and a single dose oral 0.0625 mg/kg primaquine
DP and 0.25 mg/kg primaquine	0.25 mg/kg Primaquine	DP and a single dose oral 0.25 mg/kg primaquine
DP and 0.25 mg/kg primaquine	dihydroartemisinin-piperaquine	DP and a single dose oral 0.25 mg/kg primaquine
DP and 0.125 mg/kg primaquine	0.125 mg/kg Primaquine	DP and single dose oral 0.125 mg/kg primaquine
DP and 0.5 mg/kg primaquine	0.5 mg/kg Primaquine	DP and single dose oral 0.5 mg/kg primaquine

Primary Outcome Measures

Name	Time	Method
mosquito infectivity assessed through membrane feeding	7 days	Baseline, Days 1, 2, 7

Secondary Outcome Measures

Name	Time	Method
gametocyte prevalence and density	28 days	Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28
primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite	24 hours	Hours 1, 2, 3, 4, 6, 8, 12, 24
asexual parasite prevalence and density	28 days	Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28
safety measurements including hemoglobin and signs of hemolysis	28 days	Baseline, Days 1, 2, 3, 7, 14, 28

Trial Locations

Locations (1)

Malaria Research and Training Centre; 🇲🇱 Bamako, Mali