NCT01930331

Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO

Safety, Tolerability, Pharmacokinetics and Efficacy, Phase Iv, Open Label Study of Fixed Arco® and Eurartesim® Therapies in Adults and Children With Uncomplicated P. Falciparum Malaria in Tanzania

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ifakara Health Institute · Academic / Other
• Sex: All
• Age: 6 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Phase IV, single center, 2 arms randomized controlled, open label study. Study will be conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics and efficacy of ARCO.

Detailed description

Evaluation of safety and tolerability of the administration of ARCO and Eurartesim in terms of blood biochemistry, full blood count, ECG assessments, vital signs and adverse events profile in patients with uncomplicated P. falciparum malaria. Dihydroartemisinin/piperaquine will be used as comparator.

Conditions

• Plasmodium Falciparum
• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	artemisinin/naphthoquine	Each tablet of ARCO (artemisinin/naphthoquine) contains 125 mg artemisinin and 50 mg of naphthoquine. The total dose for adults will be 1000mg of artemisinin and 400mg of naphthoquine in a fixed oral dose (ARCO tablet). The regimen for children will be calculated according to the body weight (20mg artemisinin + 8mg naphthoquine per kg body weight in a fixed oral dose(ARCO tablet)).
DRUG	dihydroartemisinin/piperaquine phosphate	Eurartesim (dihydroartemisinin/piperaquine phosphate) is a fixed dose preparation with two dose-strengths (20 mg dihydroartemisinin and 160mg of piperaquine phosphate and 40mg dihydroartemisinin and 320mg of piperaquine phosphate. The regimen for patients with body weight of 36-75kg is three tablets of 40mg dihydroartemisinin and 320mg of piperaquine phosphate once daily for three consecutive days. Those beyond or below this range the regimen will be calculated based on the body weight.

Timeline

• Start date: 2014-01-07
• Primary completion: 2014-07-27
• Completion: 2015-06-01
• First posted: 2013-08-28
• Last updated: 2018-03-14

Locations

1 site across 1 country: Tanzania