ART-A

Affordable Resistance tests for Africa ART-A

Objective

The objective of the ART-A project is to develop an affordable HIV-1 drug resistance protocol for clinics in Africa.

Background

Link to website: ART-A

Today close to 8 people in resource-poor settings are on HIV treatment. This is an incredible accomplishment, keeping in mind that 10 years ago this figure was in the order of an estimated 50,000. However, it also involves a realistic risk for development of HIV-1 drug resistance in these countries.

HIV drug-resistance is a negative side-effect of widespread medication use of antiretrovirals, which have to be taken for life. Just think how difficult it is for most people to finish a simple antibiotic therapy of a week, or how many people stop their malaria prophylaxis once they return from their holidays. The negative effects can be seen in the fight against malaria and tuberculosis (TB). Very recently outbreaks have been recorded in Thailand and Cambodia of malaria parasites that are fully resistant to all drugs, including the “wonder drug” artemisinin. In the case of TB, outbreaks of multi-resistant tuberculosis strains are frequent and increasingly threatening.

Compared to malaria and TB, HIV mutates and replicates even much faster and it is therefore not hard to predict that large-scale development of HIV-drug resistance is looming. This is particularly true for Africa, where health systems are constrained and generally health care is severely underfunded. Poorly operating health systems can lead to reduced patient drug adherence, which is the single most important reason why resistance develops. Drug resistance can seriously undermine the long-term effects of antiretroviral therapy (ART) and thus seriously challenge the international efforts of providing ART to the developing world.

HIV drug resistance can be measured by certain laboratory tests. However, these tests are technically complex and prohibitively expensive for use in low-resource settings, like Africa. Moreover, particularly this continent suffers from a massive infection rate with an extraordinary large variety of HIV. This further complicates HIV drug resistance testing and underscores the importance of collecting more information in Africa.

Addressing the issues

In order to address the above issues a public-private consortium has joined forces on a mission to develop a generic and affordable HIV drug resistance test that can be used by health providers in Africa. In other words: an Affordable Resistance Test for Africa (ART-A).

The ART-A project has developed protocols that can be applied in different healthcare settings in Africa. These protocols cover all phases from taking a blood sample to the final test interpretation and are currently being optimized for maximum applicability and affordability. Simultaneously the financial implications of different resistance protocols are calculated. By 2011 the full protocols for ARTA had been developed and field testing in various African settings, including Uganda and South Africa has been performed subsequently. Results are being published.

The attractiveness of the ART-A project is also reflected in its dedication to build capacity in Africa, for example by transfer of technology, by supporting 2 PhD programs of African scientists and by training doctors, counselors and laboratory technicians involved in the program.

The first phase of ARTA (ARTA I, 2007-2012) focused on the development and validation of an affordable drug resistance testing algorithm comprising a semi quantitative HIV viral load (the so called VFA: viral failure assay and an Reverse transcriptase-based, one-step HIV drug resistance genotyping test (Ultralight HIV genotyping assay). The algorithm was specifically developed to be applied on dried blood spot (DBS).

The objectives of the second phase of ART-A (ART-A II, 2013-2015) are geared toward a 1) larger clinical evaluation of the ARTA tests in the real-life situation of patients on treatment in three HIV clinics in Uganda, 2) resolving questions around intellectual property protection of the ART-A assay, in order to ensure its availability in resource-poor setting, 3) demonstrating the proof–of-principle that ART-A test kits can be produced independently by an African setting (Joint clinical research Center, JCRC) in a sustainable way. The ART-A II objectives will also aim at obtaining WHO accreditation for the ART-A algorithm, in order to support the clinical utilization of the assay and its contribution to WHO-recommended HIVDR prevention strategy in sub Saharan African settings.

Publications

Click here to view all ART-A publications

Summary

Name: ART-A: Affordable Resistance tests for Africa ART-A
Status: Active
Principal Investigator: Prof. dr. T.F. Rinke de Wit
Departments(s): AMC Department of Global Health
Partners: Contract laboratory services (CLS), Johannesburg, South Africa*

AIGHD, The Netherlands*

Centre de Recherche Public de la Santé (CRP), Luxemburg

University Medical Centre Utrecht (UMCU) Department of Virology, Utrecht, The Netherlands*

Wits health Consortium, Johannesburg, South Africa*

Virco BVBA (now part of Janssen diagnostics, Mechelen, Belgium

Joint Clinical Research Centre (JCRC), Kampala, Uganda*

*active in ARTA phase 2

Contact information: Clinical project manager: Corry Manting-de Vries (c.manting@aighd.org)

Project manager: Julien Schrijver (j.schrijver@aighd.org)

Duration: Start date:  1 January 2012

Duration: 42 months

End date: 1 January 2016

Funded by: Funded by African partnership for capacity development and clinical interventions against poverty-related diseases (NACCAPII): ART-A phase I, ART-A phase II
Countries: Netherlands
South Africa
Uganda
Publications: