Microbicide research in Namibia?
Subject: Anti-infective agents (Chemical properties)
Anti-infective agents (Product development)
Anti-infective agents (Health aspects)
HIV infection (Prevention)
Author: Baumgarten, Robin
Pub Date: 06/01/2008
Publication: Name: Sister Namibia Publisher: Sister Namibia Audience: Academic; General Format: Magazine/Journal Subject: Social sciences; Women's issues/gender studies Copyright: COPYRIGHT 2008 Sister Namibia ISSN: 1026-9126
Issue: Date: June, 2008 Source Volume: 20 Source Issue: 2
Topic: Event Code: 331 Product development
Product: Product Code: 2834800 Antiinfective Preparations NAICS Code: 325412 Pharmaceutical Preparation Manufacturing SIC Code: 2834 Pharmaceutical preparations
Geographic: Geographic Scope: Namibia Geographic Code: 6NAMI Namibia
Accession Number: 184549996
Full Text: "ABC is irrelevant for many women throughout the world. That is why we are developing microbicides, to provide women with a prevention option they can control with or without their partner's knowledge," says Dr. Zeda Rosenberg of the International Partnership for Microbicides (IPM). Zeda and Dr. Annalene Nel, also of IPM, recently met with the Ministry of Health and Social Services, as well as NGOs working in the field of women's rights, HIV and Aids to assess the possibility of IPM conducting clinical trials on microbicides here in Namibia.

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Why microbicide?

The microbicide field was started in the early 1990s by feminist activists. As members of the reproductive health movement, they wanted to give women a method of HIV prevention that they could control. According to the Global Coalition on Women and Aids (a UNAIDS initiative), "Women are twice more likely than men to contract HIV from a single act of unprotected sex, but they remain dependent on male cooperation to protect themselves from infection. Women need methods to protect themselves from HIV that they can control. One of the most promising prevention options on the horizon is microbicides."

How microbicides work

Microbicides are gels, creams, films or suppositories that can be applied inside the vagina to protect against HIV and other sexually transmitted infections. There are four main ways that microbicides work to prevent infection: killing or inactivating pathogens, strengthening the body's normal defenses, blocking viral entry, or inhibiting viral replication. Eventually, microbicide products will probably combine a variety of these approaches in order to maximise their effectiveness.

A microbicide called dapravine is currently being developed by IPM. Dapravine is designed to specifically target HIV and utilises ARV compounds to do so. It works by preventing or interrupting HIV replication in human cells and comes in two forms. The gel form may be applied once a day to provide protection and does not need to be applied within a certain period of time before sexual intercourse. A second form of delivery, the vaginal ring, is inserted into the vagina once per month. Ideally, this would provide women with a tool to protect themselves that would not oblige them to involve their partner.

Product development and clinical research

At present, an effective microbicide is not available. According to the World Health Organisation, there are 23 microbicide products currently being developed and researched all over the world. Virtually all of the entities developing the product are small biotechnology companies, nonprofit organisations and academic institutions. According to Zeda, "Pharmaceutical companies don't see the potential for profit in developing microbicides so they don't want to invest in them, but they have been partnering with us by giving us license to use their ARVs."

In order for a microbicide product to be made available globally, it must go through three phases of human clinical study. Phase I is a safety study that enrols a small group of people to evaluate a product's safety. This includes identifying a safe dosage range, determining side effects, and measuring acceptability of the product to trial volunteers. This phase of the study is expanded to include a larger group of people for a longer period of time in Phase II studies. Phase III studies are efficacy studies. This phase of research tests a product's ability to actually protect people from HIV infection. Large numbers of people are enrolled in these studies referred to as Phase III trials.

Phase III trials

The microbicide field took a blow in January 2007, when researchers decided to prematurely stop a Phase III study of the candidate microbicide cellulose sulfate. The sponsors and researchers opted for an early end to the test because they found a higher number of HIV infections in the group which had been using the microbicide compared with the placebo group. Sponsored by CONRAD, the study was conducted in Benin, India, South Africa and Uganda. A second study on the same product in Nigeria was also stopped because of the safety concerns in the first trial. This study had been sponsored by Family Health International. Cellulose sulfate was one of four compounds being evaluated in large-scale studies of effectiveness among women at high risk of HIV infection. At present there is no explanation for this higher rate of transmission of HIV. Currently there are three other Phase III microbicide studies under way. Results from these studies are expected in 2008 and 2009.

IPM clinical trials

IPM is sponsoring microbicide safety studies at research centres in Belgium, Kenya, Rwanda, Tanzania and South Africa and is currently identifying and building research capacity for efficacy (Phase III) studies of dapivirine and other candidate microbicides at twenty additional sites. They are interested in establishing a centre in Namibia and are currently seeking the support of the Namibian government, NGOs and local communities.

According to IPM, establishing a research site is a long process that involves working with the national government's ethics board, selecting an appropriate location within the country, identifying a community partner, developing community outreach and education, training a research team, and recruiting eligible participants and informing them of their rights and the risks involved with participating in the trial.

Jennifer Gatsi Mallet of the International Community of Women Living with HIV shared some of her thoughts on microbicide trials in Namibia. "As long as this is done with morality - that means appropriate information to the women, back-up support put in place in case of infection, life long support, emotional support, and financial support - I do not have reservations about the trials. However," she adds, "I would not want to see women being used and dumped if the trial fails or if they become infected. There should be widespread consultation with women and girls to collect data on their thoughts about microbicides being introduced in Namibia."

If a country does choose to participate in these efficacy trials, IPM will recruit women who are at high risk of HIV infection to take part in the study. Participants will receive prevention counselling and testing and treatment for all STIs. They will also receive condoms. IPM will provide anyone becoming infected with HIV during the course of the study with ARV treatment and will pay for the treatment until national HIV programmes provide this care.

If the microbicides prove effective, countries that have participated in these efficacy studies will receive priority when they become available globally. According to IPM, microbicides could be available in five to seven years.

To learn more about microbicides visit www.microbicides2008.com, the official website of the International Conference on Microbicides.
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