Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Treatments for HIV-visceral leishmaniasis co-infected patients

06.10.2014

Phase III clinical study in Ethiopia launched to test 2 treatments for HIV-visceral leishmaniasis co-infected patients

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


Migrant workers are one of the highly vulnerable, HIV-VL (visceral leishmaniasis) most-affected populations.

Credit: @ Don Paul-DNDi

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.

'Combining better initial cure treatments and preventing relapses will be a major step forward for our patients, who today fear that the diseases, which can be managed when they occur separately, often become a death sentence when they occur together. We have to do all we can to provide the most affected, a highly vulnerable migrant population, with an appropriate response', said Dr Ermias Diro, Principal Site Investigator, University of Gondar.

The Phase III clinical study conducted in Gondar and Abdurafi, Ethiopia, 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). 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.

'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', said Dr Jorge Alvar, Head of Leishmanisis Programme, DNDi.

This clinical trial is conducted by DNDi (sponsor) in collaboration with MSF-Holland (co-sponsor); the University of Gondar (UoG), Ethiopia; the Institute of Tropical Medicine (ITM) Antwerp, Belgium; the London School of Hygiene & Tropical Medicine, UK; and is funded by the European Union (EU FP7); the Swiss Agency for Development and Cooperation (SDC), Switzerland; Médecins Sans Frontières; the Federal Ministry of Education and Research (BMBF) through KfW, Germany; the Medicor Foundation, Liechtenstein; and other private donors.

About the study:

  • Overall objective: identify a safe and effective treatment for VL in HIV co-infected patients 

     

  • Study design: a randomized, parallel arm, open-label clinical study

     

     

  • Treatment dosing schedule:
    • AmBisome® monotherapy: 40mg/kg total dose: intravenous infusion 5mg/kg on day 1-5, 10, 17, 24
    • AmBisome®: 30mg/kg total dose: intravenous infusion 5mg/kg on day 1, 3, 5, 7, 9, 11 and miltefosine: every day for 28 days, with 50mg/day (for patient weighting ≤ 25 kg) and 100 mg/day (for patient weighting > 25 kg)

     

     

  • Study duration:
    • Treatment duration is 28 days or 56 days in case of extended treatment (if tissue aspirate is parasite positive at day 29 and the patient is well). When the patients are tested parasite negative, they are eligible for a secondary prophylaxis – pentamidine 4mg/kg intramuscular injection or intravenous infusion once a month – and enter a one-year follow-up phase. At any stage as of day 29, if the patients are unwell, they receive a rescue therapy.

     

     

  • AmBisome® supply for the study is donated by Gilead. Pentamidine supply for the study is donated by Sanofi.

     

About visceral leishmaniasis (VL or kala-azar)

Visceral leishmaniasis is a neglected tropical disease caused by Leishmania donovani or L. infantum. There are an estimated 300,000 new cases of VL per annum. Fatal if left untreated, the disease approximately kills 40,000 people every year. 90% of cases occur in Sudan, Ethiopia, Kenya, Bangladesh, India, Nepal, and Brazil. VL is characterized by prolonged fever and splenomegaly. The current VL therapies administered include pentavalent antimonials [sodium stibogluconate (SSG) and meglumine antimoniate], AmBisome®, miltefosine, and paromomycin (PM).

About AfriCoLeish: http://www.africoleish.org

A research and development (R&D) international consortium, AfriCoLeish is supported by the European Union Seventh Framework Programme (EU FP7) through a grant of €3 million. The project aims to test new treatments for visceral leishmaniasis (VL or kala-azar) in East Africa and co-infection of the disease with HIV in Ethiopia. AfriCoLeish brings together six organizations from Europe and East Africa with vast experience in R&D and treatment of HIV and kala-azar, namely:

Press contact:

Renee Olende, Regional Communications Manager, DNDi Africa
Mobile: +254 705 639 909 / E-mail: rolende@dndi.org

Violaine Dällenbach | Eurek Alert!

Further reports about: HIV Medicine Tropical Medicine diseases intravenous parasite visceral leishmaniasis

More articles from Life Sciences:

nachricht Designed proteins to treat muscular dystrophy
29.06.2017 | Universität Basel

nachricht Funding of Collaborative Research Center developing nanomaterials for cancer immunotherapy extended
28.06.2017 | Johannes Gutenberg-Universität Mainz

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

Im Focus: Scientists develop molecular thermometer for contactless measurement using infrared light

Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine

Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

High conductive foils enabling large area lighting

29.06.2017 | Power and Electrical Engineering

Designed proteins to treat muscular dystrophy

29.06.2017 | Life Sciences

Climate Fluctuations & Non-equilibrium Statistical Mechanics: An Interdisciplinary Dialog

29.06.2017 | Seminars Workshops

VideoLinks
B2B-VideoLinks
More VideoLinks >>>