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Phase2a Primaquine Dose Escalation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743820
First Posted: December 6, 2012
Last Update Posted: January 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Malaria Research and Training Center, Bamako, Mali
Shoklo Malaria Research, Tak, Thailand
Mahidol Oxford Tropical Medicine Research Unit
Bill and Melinda Gates Foundation
Wellcome Trust
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention Phase
Malaria Drug: dihydroartemisinin-piperaquine Drug: 0.125 mg/kg Primaquine Drug: 0.5 mg/kg Primaquine Drug: 0.25 mg/kg Primaquine Drug: 0.0625 mg/kg Primaquine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • mosquito infectivity assessed through membrane feeding [ Time Frame: 7 days ]
    Baseline, Days 1, 2, 7


Secondary Outcome Measures:
  • gametocyte prevalence and density [ Time Frame: 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 [ Time Frame: 24 hours ]
    Hours 1, 2, 3, 4, 6, 8, 12, 24

  • asexual parasite prevalence and density [ Time Frame: 28 days ]
    Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

  • safety measurements including hemoglobin and signs of hemolysis [ Time Frame: 28 days ]
    Baseline, Days 1, 2, 3, 7, 14, 28


Enrollment: 81
Study Start Date: September 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dihydroartemisinin-piperaquine only
dihydroartemisinin -piperaquine (DP) only
Drug: dihydroartemisinin-piperaquine
Experimental: DP and 0.125 mg/kg primaquine
DP and single dose oral 0.125 mg/kg primaquine
Drug: dihydroartemisinin-piperaquine Drug: 0.125 mg/kg Primaquine
Experimental: DP and 0.5 mg/kg primaquine
DP and single dose oral 0.5 mg/kg primaquine
Drug: dihydroartemisinin-piperaquine Drug: 0.5 mg/kg Primaquine
Experimental: DP and 0.25 mg/kg primaquine
DP and a single dose oral 0.25 mg/kg primaquine
Drug: dihydroartemisinin-piperaquine Drug: 0.25 mg/kg Primaquine
Experimental: DP and 0.0625 mg/kg primaquine
DP and a single dose oral 0.0625 mg/kg primaquine
Drug: dihydroartemisinin-piperaquine Drug: 0.0625 mg/kg Primaquine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743820


Locations
Mali
Malaria Research and Training Centre
Bamako, Mali
Sponsors and Collaborators
University of California, San Francisco
Malaria Research and Training Center, Bamako, Mali
Shoklo Malaria Research, Tak, Thailand
Mahidol Oxford Tropical Medicine Research Unit
Bill and Melinda Gates Foundation
Wellcome Trust
Investigators
Principal Investigator: Roland Gosling, MD, PhD University of California, San Francisco
Principal Investigator: Alassane Dicko, MD Malaria Research and Training Centre
Principal Investigator: François Nosten, MD Shoklo Malaria Research Unit
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01743820     History of Changes
Obsolete Identifiers: NCT02011555
Other Study ID Numbers: MEG001
First Submitted: November 26, 2012
First Posted: December 6, 2012
Last Update Posted: January 19, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Primaquine
Piperaquine
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents