Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which:

• Two or fewer participants (< 30%) experience hemolysis;

• No participant experiences a drug-related serious adverse event; and

• No participant requires a blood transfusion.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; Malaria Research and Training Center, Bamako, Mali; Radboud University; University of Mississippi Medical Center
• Treatments: Primaquine

Criteria

Inclusion Criteria:

• Males ages 18- 50 (inclusive)

• Ability to swallow oral medication

• Informed consent

• Willing and able to participate in the study for 28 days

For the G6PDd participants:

• G6PDd defined by Carestart 3 rapid diagnostic test or

• The OSMMR2000 G6PD qualitative test

For the G6PDn participants:

• G6PDn defined by Carestart 3 rapid diagnostic test or

• The OSMMR2000 G6PD qualitative test

Exclusion Criteria:

• Moderate to severe anemia (Hb < 10 g/dL)

• Malaria infection by blood smear

• Individuals with known positive HIV test

• Individuals with known positive hepatitis B test.

• Known allergy to study drugs

• Current use of medication (for tuberculosis, HIV, or any drugs that have hemolytic potential in G6PDd individuals including sulphonamides, dapsone, nitrofurantoin, nalidixic acid, ciprofloxacin, methylene blue, toluidine blue, phenazopyridine, and co-trimoxazole)

• The individual is unwilling to abstain from the ingestion of grapefruit-containing products from 72 hours prior to the start of dosing until the study is complete

• Use of antimalarials within 2 weeks before contact with the study team as reported by the patient

• History of blood transfusion or a bleed of > 500 mLs within the last 3 months, as reported by the patient

• Reported history of high alcohol intake (> 14 units per week, each unit is equivalent to 10 g of alcohol (1 glass of wine or 1 bottle of beer or one shot of distilled spirits), within 6 months of study as reported by the patient

• Reported use of illicit drugs (marijuana, heroin, cocaine, methamphetamine) or dependence within 6 months of study, as reported by the patient

• Participants who vomit within 1 hour after administration of primaquine (will be removed from the analysis and will not count towards the total sample size, though they will be followed as any other enrolled individual)

• Already enrolled in this study.