Coarsucam

We conducted an open-label, parallel-arm, pharmacokinetic (PK) trial at Queen Elizabeth Central Hospital, Malawi, from August 2010 to March 2013. The study was implemented in two steps.
In step 1 (n = 18) (PACTR2010030001871293), we administered half adult oral doses of AS-AQ (1 tablet of Coarsucam [Sanofi-Aventis], containing AS and AQ at 100 mg and 270 mg) at 0, 24, and 48 h, to HIV⁺ malaria-negative individuals in the following arms: (i) those on NVP-stavudine (d4T)-lamivudine (3TC), (ii) those on zidovudine (AZT)-3TC-tenofovir disoproxil fumarate (TDF)-LPV/r, and (iii) antiretroviral-naive individuals, who served as a control arm. Step 1 served as a safety evaluation step, checking for unexpected clinical toxicities or interactions.
In step 2 (n = 75) of the study (PACTR2010030001971409), after review of step 1 safety data by an independent data safety monitoring board (DSMB), full treatment doses of AS-AQ (2 tablets of Coarsucam [Sanofi-Aventis], each containing AS and AQ at 100 mg and 270 mg) were administered to additional HIV⁺ individuals in the same arms and at the same intervals as in step 1.
All doses of AS-AQ were administered with water only, as recommended by Sanofi-Aventis.

Enrolled patients were treated with AL or AS–AQ. AL (one tablet containing artemether 20 mg and lumefantrine 120 mg; Coartem™; Novartis, Basel, Switzerland) was administered twice daily for 3 days (six doses in total) with dosage determined according to body weight: one tablet for children 5–15 kg and two tablets for children 15–25 kg. AS–AQ (Coarsucam™; Winthrop; Sanofi Aventis, Paris, France) was administered once daily according to body weight: 25 mg artesunate/67.5 mg amodiaquine for children 4.5–9 kg; 50 mg artesunate/135 mg amodiaquine for children 9–18 kg; 100 mg artesunate/270 mg amodiaquine for children 18–36 kg [17 ]. Both drugs were administered with food. All treatments were directly supervised for a minimum of 30 min at the health facility. For vomiting occurring within the first 30 min the full treatment dose was readministered. For patients living far away from the health centers, and those for whom direct observation of the evening doses of AL was challenging, admission was offered for the first 3 days of the study.
Antipyretics, such as paracetamol, were used to control fever. In case of development of severe malaria or danger signs, the patient was hospitalized and received parenteral artesunate. Rescue therapy according to national treatment guidelines was also administered in cases of early or late treatment failure [18 ].