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MDP Statement on the discontinuation of tenofovir gel in the VOICE trial
16th January 2012
Following a recommendation by the independent Data and Safety Monitoring Board after their review on the 17th November 2011, the Microbicide Trials Network (MTN) and the US National Institutes of Health (NIH) has decided to discontinue evaluation of daily tenofovir gel in VOICE, a major HIV prevention trial being conducted among women in South Africa, Uganda and Zimbabwe.
Interim analysis revealed that there was no possibility of demonstrating benefit from the daily use of tenofovir gel. In September, the network decided to discontinue evaluation of tenofovir tablets following a similar recommendation from the Data and Safety Monitoring Board. More details are available on the MTN website http: www.mtnstopshiv.org
The trial will continue to evaluate the safety and effectiveness of daily Truvada oral tablets and results are expected in early 2013.
This latest VOICE finding is in contrast with the results of the CAPRISA 004 study which demonstrated a 39% reduction in HIV among women allocated to use tenofovir gel before and after sex. The final analysis of the VOICE data will provide important insight into the factors that underlie the differences in these results.
The MDP investigators recognise the importance of adherence and that daily dosing with vaginal gel could be challenging for women. The question of whether or not a single dose of tenofovir gel applied prior to sex could protect women from HIV remains an important one and is still a priority for the MDP. We will continue to try and raise funds to address this issue in a randomised clinical trial.
The Microbicides Development Programme (MDP) is a not-for-profit, African-European partnership, which was established to develop vaginal microbicides to reduce the risk of HIV infection in women. It was launched in 2000 to prepare for a large scale HIV prevention field trial following earlier research that had identified two promising candidates. The partnership is coordinated jointly by Imperial College London, and the Clinical Trials Unit of the UK Medical Research Council, which has been working on clinical trials with African partners for over 30 years.
MDP conducts clinical trials to test the safety and effectiveness of potential microbicides. It also carries out research in basic science, models the potential impact of microbicides and explores factors surrounding their acceptability.
MDP partners include 16 institutions in Africa and Europe. As well as medical scientists and clinicians, the partnership encompasses social anthropologists and health economists who can help ensure that the women most in need of microbicides will find these products acceptable, affordable and easy to use. Social science and marketing considerations have been integrated into MDP to an unprecedented degree, with behavioural findings used in trial management as well as analysis of results. The trial is also believed to be the first of its size to have recruited volunteers directly from communities rather than exclusively from medical facilities. This was made possible by innovative community liaison structures.
MDP is funded by the UK government through the Department for International Development (DFID) and the Medical Research Council. DFIDs support represents a bold and innovative bid to address a longstanding problem, namely the fact that drugs urgently needed in poor countries are often not developed because the costs of research and development cannot be recovered commercially. MDPs contract with the product developer for the MDP 301 trial also contains provisions to help ensure affordable access for women in developing countries.
Costs of MDP are very low compared to those of the pharmaceutical industry, as the programmes infrastructure is relatively modest and the UK partners receive academic-scale salaries which are underwritten by their host universities. The programme is in the forefront of north-south research partnerships in terms of the capacity it has built in Africa, the number of high quality studies it has completed, and the degree to which it is African-led. Trial management is collegial, with significant authority vested in the southern partners. Studies are structured in such a way as to ensure that African trial sites own and control their own data. Local data management occurs on site and African investigators have direct access to their own site data for scientific papers.
The programme is managed by a Board consisting of the Principal Investigators (PIs) from each of the institutional partners in Africa and Europe. The Board meets at least once a year and, in between, devolves management to an executive committee of 4 PIs (2 from Africa, 2 from Europe), which meets quarterly to review activities and budgets. Each PI rotates through this committee, serving for one year at a time.
During the course of the programme, seven feasibility studies have been completed in 5 sub-Saharan countries, with each study run by an African academic partner. The MDP 301 phase III trial is the culmination of several years of collaborative work in the field of HIV prevention. Over 20,000 women have been screened for these studies, and 9,404 were enrolled in MDP 301. MDP identified and referred over 5,000 women who needed access to anti-retroviral therapy for HIV, thus helping clinics meet targets set by their national governments for roll-out of treatment. MDP has continued to assess potential microbicides in the laboratory, taken a second microbicide candidate from bench to clinic, conducted a clinical distribution study, and developed epidemiological and economic models to determine potential microbicide impact on the HIV epidemic.
MDP has built a vigorous multicultural and multidisciplinary research network ready to undertake future work of comparable importance and complexity. Years of working collegially have built cohesiveness, efficiency and mutual trust among the scientists, clinical staff, data managers, and other professionals and support staff comprising this African-European and pan-African clinical trial network, as well as sound relationships with surrounding communities. MDP has also achieved significant improvements in African laboratory capacity and other research infrastructure, as well as upgrading and reinforcement of professional capacity at its African research centres. MDP represents a unique and genuine partnership between African and European scientists and industry, with African scientists in leadership positions and local communities closely engaged. The Principal Investigators believe that this ethos, with its emphasis on mutual respect and support, have enabled them to deliver so many completed projects to time and within budget, and to overcome the various challenges inherent in a product development pathway.
The MDP partnership includes institutions in South Africa (Durban and Mtubatuba, KwaZulu Natal; and Johannesburg), Uganda, Tanzania, Zambia, Mozambique, Spain and the UK. The MDP 301 trial is being carried out at 3 research centres in South Africa and one each in Uganda, Tanzania and Zambia.
1 The European & Developing Countries Clinical Trials Partnership has funded an MDP feasibility study in Mozambique and the International Partnership for Microbicides contributed to the final phase of quality control monitoring of the Phase III trial, MDP 301.