A Phase III clinical study to address the extreme difficulty in treating visceral leishmaniasis (VL) in patients who also are HIV-positive has been launched by the international research & development (R&D) consortium, AfriCoLeish, formed by six research organizations from East Africa and Europe.
The study will assess the efficacy and the safety of two treatments: a combination treatment of AmBisome® and miltefosine, and AmBisome® alone. This is the first randomized clinical trial in Africa to confirm the World Health Organization's recommendation for HIV-VL treatment. Two sites, Gondar and Abdurafi, in northwest Ethiopia, one of the highest burden areas in the world, have begun recruiting patients.
HIV-AIDS and VL, fatal without treatment, both affect the immune system of the patients. When the two diseases occur together, treatment of both diseases becomes more challenging. The risk of death from VL is nine times higher in patients who are co-infected with HIV. VL also accelerates the progression of HIV. Relapses of VL in patients co-infected with HIV are also very common, affecting half of treated patients within a year of initial treatment, and overall VL cure rates are significantly lower.
An emerging global problem, VL-HIV cases are reported in 35 countries worldwide, spanning Southern Europe, East Africa, the Indian subcontinent, and Latin America. One of the hardest hit areas in Africa is northwest Ethiopia, where anywhere from 20% to 40% of patients with VL were found to be also infected with HIV.
'Treating patients that suffer both HIV and visceral leishmaniasis is a real battle for clinicians. Research strongly suggests that we need to strike the right balance between stronger treatments and safer treatments', said Koert Ritmeijer, PhD, Health Advisor, Médecins Sans Frontières.