AfriCoLeish launches Phase III study on Gilead's AmBisome in treatment of visceral leishmaniasis

AfriCoLeish, the international research and development consortium formed by six research organizations from East Africa and Europe, has launched a Phase III clinical study to address the difficulty in treating visceral leishmaniasis in patients who are HIV-positive.

The study will assess the safety profile and efficacy of two treatments: one a combination of AmBisome (amphotericin B), and miltefosine, and the other just Ambisome alone. This will be the first randomized clinical trial in Africa to confirm the World Health Organization’s recommendation for HIV-VL treatment. AmBisome is manufactured by US biotech major Gilead Sciences (Nasdaq: GILD).

Gondar and Abdurafi, two sites in northwest Ethiopia which has one of the highest burden areas in the world, have begun recruiting patients. Total treatment duration is 28 days, if the tests show that the patient is parasite-negative (at day 29). Thereafter, the patient will start a secondary prophylaxis treatment aimed at preventing VL relapses and a one-year follow-up phase. A total of 132 patients will be recruited for the trial.