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AFRIMS Concludes Pilot Malaria Prophylaxis Clinical Trial in Cambodia

11 March 2011

USAMC-AFRIMS, Department of Immunology and Medicine (AFRIMS I/M), hosted a 1 day workshop in Siem Reap to present the preliminary results of Study WR 1737, An active malaria epidemiology cohort study with evaluation of a 2 day versus 3 day treatment regimen of DHAPiperaquine for patients with uncomplicated malaria in cooperation with the Cambodian National Center for Parasitology, Entomology and Malaria Control (CNM), and the Royal Cambodian Armed Forces (RCAF).

Pilot Malaria Prophylaxis Clinical Trial in Cambodia

Photo: Official Photo from the ceremony with VIP guests in attendance including High Excellency Dr. Duong Socheat, Director CNM; Major General Kong Saly, Director RCAF Health Department, and Brigadier General Sun Kimthai, Deputy Commander, Military Region 4.

The completion of the clinical portion of the study represents the first phase in a joint project to license new antimalarial prophylaxis drugs that are effective and safe for long-term use – the first of such efforts in more than a decade. The purpose of the pilot study was to prospectively define malaria epidemiology including incidence and evidence for drug resistance. Patients developing malaria were treated with 2 or 3 days of DHA-piperaquine (DP) with equal cumulative doses. These regimens of DP are the current first line therapies for the Cambodian military and civilian populations respectively. Preliminary data indicates that there do not appear to be substantial differences in the safety or effectiveness of the two regimens, but data analysis is just beginning and expected to take up to 6 months. Data from the study remain provisional pending further analysis and integration with laboratory assessments in progress. Data will be used to inform national drug treatment policy, and to monitor for drug resistance.

During the meeting AFRIMS was praised by its partners for the successes of the first significant clinical research project ever undertaken by RCAF. RCAF leaders and soldiers at all levels consistently expressed their appreciation of the clear planning and communication, realistic expectations, cooperative ethical approach, and professionalism of the AFRIMS-CNM research team. Volunteer representatives from the study also joined the meeting, and expressed appreciation for the medical care provided, and for AFRIMS efforts to control malaria in their communities. AFRIMS and CNM were thanked by the partners for the improvements to existing field laboratory and clinical facilities that made this first regulated study possible. This included laboratory renovations at Anlong Veng Referral Hospital and a nearby RCAF dispensary, including the provision of new generators, transport capability and field laboratory diagnostic equipment by the CNM. These capacity building initiatives including a combination of professional development and materiel support were perceived by all partners as the greatest contribution to overall success.

The AFRIMS and CNM team members were presented with multiple awards by the Surgeon General, RCAF Health Department. AFRIMS in turn presented the AFRIMS Commander’s Coin to newly trained RCAF researchers who actively participated in the study, highlighting the tremendous support provided at all levels. Particular recognition was given to multiple RCAF clinical staff joining the AFRIMS-CNM research team after completing an exhaustive training program in human subjects protection and malaria diagnostics over a period of 6 months prior to study start. This group worked many long hours during the clinical portion of the study and represents a new research capability.

Pilot Malaria Prophylaxis Clinical Trial in Cambodia

Photo: AFRIMS, CNM and RCAF staff conducting study WR 1737, a pilot malaria prophylaxis study.

The mission of AFRIMS I/M is to conduct clinical trials to develop new antimalarial products for the warfighter, and epidemiology surveillance for emerging infectious diseases including drug resistant malaria. The I/M Clinical Trials unit has strong national and local partnerships with multiple health facilities in Cambodia, where it has been conducting clinical research since 2005. Field sites are in the World Health Organization’s declared ‘Zone 1 Containment Area’– believed to be the current and historical epicenter for the origination of multidrug resistant malaria. AFRIMS I/M research activity contributes to the CNM and RCAF missions to contain, control and eliminate malaria in Cambodia by providing high quality information to support new public health action.

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