Phase2a Primaquine Dose Escalation Study

January 16, 2015 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mali
      • Bamako, Mali
        • Malaria Research and Training Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mosquito infectivity assessed through membrane feeding
Time Frame: 7 days
Baseline, Days 1, 2, 7
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gametocyte prevalence and density
Time Frame: 28 days
Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28
28 days
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
24 hours
asexual parasite prevalence and density
Time Frame: 28 days
Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28
28 days
safety measurements including hemoglobin and signs of hemolysis
Time Frame: 28 days
Baseline, Days 1, 2, 3, 7, 14, 28
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Bill and Melinda Gates Foundation
Wellcome Trust
Malaria Research and Training Center, Bamako, Mali
Shoklo Malaria Research Unit
Mahidol Oxford Tropical Medicine Research Unit

Investigators

  • Principal Investigator: Roland Gosling, MD, PhD, University of California, San Francisco
  • Principal Investigator: Alassane Dicko, MD, Malaria Research and Training Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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