Overview

This trial is active, not recruiting.

Condition malaria
Treatments aq-13 treatment, coartem treatment
Phase phase 2
Sponsor Donald Krogstad
Collaborator University of the Sciences, Techniques and Technologies of Bamako
Start date August 2013
End date January 2016
Trial size 66 participants
Trial identifier NCT01614964, 2149, FDA 1R01-FD-003373

Summary

This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of Orphan Product Development (OOPD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
aq-13 treatment N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine.
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.
(Active Comparator)
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: Active Comparator: Coartem. Participants randomized to the Coartem arm will be treated with 80 mg artemether and 480 mg lumefantrine at the time of diagnosis and 8 hours later on day 1, the same doses (80 mg artemether and 480 mg lumefantrine) twice on day 2 (24 and 36 hours after diagnosis) and twice more on day 3 (48 and 60 hours after diagnosis) for total oral doses of 480 mg artemether and 2880 mg lumefantrine over 3 days.
coartem treatment Tablets contain 20 (or 80) mg artemether and 120 (or 480) mg lumefantrine.
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.

Primary Outcomes

Measure
The primary outcome of this study is a comparison of the cure rates of AQ-13 and Coartem for uncomplicated Plasmodium falciparum malaria in adult Malian males.
time frame: Subjects are followed for 42 days after beginning treatment with either AQ-13 or Coartem..

Secondary Outcomes

Measure
Frequency of adverse events
time frame: within 4 weeks of beginning treatment with either AQ-13 or Coartem
Parasite Clearance Time
time frame: from the time of beginning treatment with either AQ-13 or Coartem to the first of 2 successive negative blood smears
Time to recrudescence of reinfection
time frame: within 42 days after beginning treatment with either AQ-13 or Coartem
Effects of antimalarial treatment on the QT (QTc) interval.
time frame: within 14 days of beginning treatment with either AQ-13 or Coartem
Pharmacokinetic parameters for AQ-13
time frame: These studies will continue for the entire 42 day follow-up period.
Fever Clearance Time
time frame: Days 1-7 after beginning treatment with either AQ-13 or Coartem

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria 1. Adult Malian males ≥ 18 years of age, 2. Uncomplicated malaria with ≥ 2,000 asexual P. falciparum parasites per ul, and 3. Informed consent obtained and signed. Exclusion Criteria 1. Severe or complicated malaria (including temperature ≥ 40o C), 2. ≥ 100,000 asexual parasites per ul of blood, 3. Anemia or other laboratory results (other than malaria) that require treatment (e.g., Hb ≤ 7 gm/dL, K+ ≤ 3.5 millimolar (mM), BP ≥ 140/90), 4. Seizures or impaired consciousness, 5. Recent antimalarial treatment by history (within ≤ 2 weeks), 6. Chronic medications (including inducers of Cytochrome P450 3A4 [CYP3A4] activity such as rifampin and nevirapine), 7. Ventricular or atrial arrhythmias, or second or third degree heart block on the screening ECG or Holter recording, 8. Infection with other plasmodial species on the blood smear (P. ovale, P. ovale, P. vivax).

Additional Information

Official title Phase 2 Proof of Concept Study of a Candidate Aminoquinoline Antimalarial (AQ-13)
Principal investigator Donald J. Krogstad, MD
Description This is an initial efficacy study (Phase 2 Proof of Concept Study) of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Tulane University Health Sciences Center.