Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

January 31, 2016

Study Completion Date

February 28, 2017

Conditions
Malaria
Interventions
DRUG

AQ-13 Treatment

Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days.

DRUG

Coartem Treatment

Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'Coartem Treatment' Participants randomized to the Coartem arm will receive six doses of Coartem tablets over 3 days (each dose containing 80 mg artemether and 480 mg lumefantrine). Those six doses will be given at the time of diagnosis and 8 hours later on day 1, at 24 and 36 hours on day 2 and at 48 and 60 hours on day 3 for total doses of 480 mg artemether and 2880 mg lumefantrine over 3 days.

Trial Locations (1)

BP 1805

Clinical Research Center (Hopital Point G, University of the Sciences, Techniques and Technologies of Bamako), Bamako

All Listed Sponsors
collaborator

University of the Sciences, Techniques and Technologies of Bamako

OTHER

lead

Tulane University

OTHER

NCT01614964 - Studies of a Candidate Aminoquinoline Antimalarial (AQ-13) | Biotech Hunter | Biotech Hunter