Phase2a Primaquine Dose Escalation Study

This study is currently recruiting participants.
Verified October 2013 by University of California, San Francisco
Sponsor:
Collaborators:
Malaria Research and Training Centre, 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
ClinicalTrials.gov Identifier:
NCT01743820
First received: November 26, 2012
Last updated: October 8, 2013
Last verified: October 2013
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    Baseline, Days 1, 2, 7


Secondary Outcome Measures:
  • gametocyte prevalence and density [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Hours 1, 2, 3, 4, 6, 8, 12, 24

  • asexual parasite prevalence and density [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

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


Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743820

Contacts
Contact: Roland Gosling, MD, PhD 415 597 8114 goslingr@globalhealth.ucsf.edu

Locations
Mali
Malaria Research and Training Centre Recruiting
Bamako, Mali
Contact: Alassane Dicko, MD    +223-6674-2296    adicko@icermali.org   
Principal Investigator: Alassane Dicko, MD         
Thailand
Shoklo Malaria Research Unit Not yet recruiting
Mae Sot, Thailand, 63110
Contact: Francois Nosten, MD    +66 (0) 55 545 021    francois@tropmedres.ac   
Principal Investigator: Francois Nosten, MD         
Sponsors and Collaborators
University of California, San Francisco
Malaria Research and Training Centre, 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, 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:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01743820     History of Changes
Other Study ID Numbers: MEG001
Study First Received: November 26, 2012
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board
Mali: comités d'éthique
Thailand: Ethical Committee

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Primaquine
Dihydroquinghaosu
Artemisinins
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014