Gilead's AmBisome In Phase 3 Trials For HIV-Visceral Leishmaniasis Co-Infected Patients

AfriCoLeish, an international R&D consortium, has begun a Phase 3 study of Gilead’s AmBisome in African patients co-infected with HIV and visceral leishmaniasis (VL). The Drugs for Neglected Diseases initiative (DNDi), an AfriCoLeish member, announced the clinical trial in a press release, stating that it will assess AmBisome, donated by Gilead, as a monotherapy and AmBisome in combination with Impavido (miltefosine), an Endo therapeutic. Patients who do not undergo treatment failure will be given prophylactic treatment with Pentamidine, donated by Sanofi.

Dr. Jorge Alvar, Head of Leishmanisis Program at DNDi, said, “Visceral leishmaniasis, notably in East Africa, is among the most neglected of all neglected tropical diseases. The work of this consortium to address the additional challenge of co-infection with HIV in Ethiopia is vital as it has begun to tackle one of the most challenging endemic areas and aspects of this fatal disease.”

AmBisome

AmBisome is a liposomal formulation of amphotericin B, administered by intravenous injection. The agent treats infections caused by fungus, including leishmaniasis and a certain forms of meningitis. Based on a 2010 study, the World Health Organization (WHO) recommends AmBisome as a first-line treatment for VL. In December 2011, Gilead announced that it was donating 445,000 vials of AmBisome to WHO to treat 50,000 patients with VL over five years.

African AmBisome Study

AfriCoLeish’s new study will take place in Africa, as VL is widespread in Africa and South Asia. The VL parasite spreads through sand fly bites, attacking organs and increasing infection. HIV sufferers with compromised immune systems are nine times more likely to face death, as VL accelerates HIV progression. Ethiopa is one of the hardest hit areas in Africa for VL/HIV as 20 to 40 percent of patients with VL are also HIV positive.

The new study is sponsored by AfriCoLeish members including DNDi, the Institute of Tropical Medicine (ITM), the London School of Hygiene & Tropical Medicine, Médecins Sans Frontières, the Institute of Endemic Diseases at the University of Khartoum, and the University of Gondar. Gondar and Abdurafi, in Ethiopia, have begun recruiting patients for the study.

The Phase 3 clinical study will assess the efficacy and safety of the combination of AmBisome (30mg/kg total dose) and miltefosine (50mg or 100mg/day depending on the patient’s weight), and AmBisome alone (40mg/kg total dose) in a total of 132 patients. Investigators will complete the data collection for the primary outcome measure by January 2016.