All drug candidates first go through a rigorous program of laboratory screening and testing to ensure that they are safe before being tested in humans. This program of extensive preclinical testing can take several years. Once a candidate is deemed safe, it goes through a series of human clinical trials. These trials are conducted first to determine safety, and then to test efficacy, or the ability to prevent HIV infection. Only after these trials have been completed will a candidate drug be considered for licensure and distribution.
Frequently Asked Questions
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How are microbicides tested?
How are the rights of participants in microbicide trials protected?
IPM has a number of protocols in place to ensure that every volunteer is not only protected, but also educated in the clinical trial process through an ongoing informed consent process. IPM established these protocols in accordance with those set by international regulatory bodies, including those countries hosting trials and the International Conference on Harmonization.
Each IPM-supported clinical research centre has a community advisory process and a community engagement plan. Participants receive counseling and testing for sexually transmitted infections (STIs), hear presentations on the clinical trials process and informed consent, and participate in discussions on safer sex practices. All participants are encouraged to use condoms, which are provided free of charge by the research centers.
How are women’s preferences considered in HIV prevention drug development?
Effectiveness is influenced by acceptability. Even the most efficacious microbicide drug developed will not work if it is not used consistently and correctly. IPM has conducted product acceptability studies to gather information on the preferences of women and their male partners. Results of these studies demonstrate the need for microbicides in a variety of forms that women use discreetly, independent of the time of sex.
How do microbicides work?
Unlike antiretroviral (ARV) therapy, which treats HIV infection throughout the body after an infection has already occurred, vaginal microbicides would prevent infection from taking hold in the first place. HIV’s life cycle presents a number of points at which microbicides act to prevent infection. Some microbicides interfere with the ability of HIV to attach to or enter human cells. Others prevent the virus from reproducing once the virus has already entered the cell. Microbicides will ultimately be delivered in a variety of forms — such as a vaginal rings, gels, films or tablets.
How does IPM work?
As a PDP, IPM seeks to marshal expertise and resources in the private sector to advance microbicide research. IPM establishes agreements with private companies that allow it to develop industry products for use as microbicides in developing countries.
To date, IPM has acquired royalty-free licenses to develop, manufacture and distribute antiviral compounds as microbicides in developing countries from six major drug companies. Tibotec Pharmaceuticals, Ltd. (a subsidiary of Johnson & Johnson) licensed dapivirine (TMC120) to IPM in March 2004. In October 2005, Merck and Co., Inc. and Bristol-Myers Squibb each licensed antiretroviral drugs. Gilead Sciences, Inc. granted IPM and CONRAD the rights for tenofovir in December 2006. In 2008, IPM received licenses from Pfizer for maraviroc and from Merck for L’644 (DS007).
How will IPM ensure that women in developing countries get timely and affordable access to HIV prevention drugs?
IPM is committed to assuring women at high risk of becoming HIV infected in developing countries have rapid access to microbicides that have been found to be safe and effective. IPM continues to explore partnerships in a number of African countries to ensure that, once the first approved microbicide is ready for use, it will be accessible in as many communities and countries as possible.
If vaginal microbicides are meant for women, are men involved too?
Men play an important role in the fight against HIV. Men are also being included in some clinical trials to help determine if vaginal microbicides are safe and acceptable to male partners. In addition, some researchers are testing rectal microbicides for both men and women to use. A rectal microbicide would also be an important tool to slow the spread of HIV.
What are microbicides?
Microbicides are topical products being developed to reduce the transmission of HIV during sexual intercourse. Antiretroviral (ARV)-based vaginal microbicides could take the form of a monthly vaginal ring, daily gel, film or tablet. In an approach known as pre-exposure prophylaxis (PrEP), ARV drugs might be administered systemically to prevent HIV. These products could take the form oral tablets, long-acting injections or other novel formulations. Microbicides will be a useful complement to other HIV-prevention measures. These include education on safer sex, condom use and distribution, voluntary testing and counseling, identifying and treating HIV-positive individuals (test and treat), producing and enacting anti-stigma campaigns and providing access to safe blood supplies.
What are the Millennium Development Goals?
The Millennium Development Goals were adopted by 189 United Nations member states in 2001 with an objective for meeting them by 2015. The eight goals create a universal framework for development that envisions a better future for all people. The goals are:
- Eradicate extreme poverty and hunger
- Achieve universal primary education
- Promote gender equality and empower women
- Reduce child mortality
- Improve maternal health
- Combat HIV/AIDS, malaria and other diseases
- Ensure environmental sustainability
- Develop a global partnership for development
Microbicides represent a potentially powerful tool to meet goals 1, 2, 5 and 6. Without focused, sustained progress in reducing women’s risk of HIV infection, these goals are unlikely to be achieved.
What do the CAPRISA 004 trial results mean for HIV prevention and microbicide research?
The Centre for the AIDS Programme of Research in South Africa (CAPRISA) study is an important milestone for HIV prevention. CAPRISA 004 was the first trial to test the efficacy of an ARV-based drug, tenofovir. The study found a 39 percent lower HIV infection rate in women using 1% tenofovir gel as compared to those women using a universal placebo gel.
These efficacy results are statistically significant and represent the first “proof of concept” for a topical microbicide. For the first time, the HIV prevention research community has evidence that topically applied ARVs can offer protection against HIV and potentially other pathogens.
Confirmatory studies may be needed to establish definitive proof of the effectiveness of tenofovir gel. Research on other microbicides must continue. It is important to develop a number of safe and effective microbicides that attack HIV at different points in its life cycle and that provide a choice of easy-to-use protection options for women. A number of such “next generation” candidates — such as IPM’s dapivirine ring formulation — have advanced into safety studies and are progressing toward efficacy trials.
What is a product development partnership (PDP)?
IPM’s model, which brings together private sector technologies and public sector resources, is built on successful partnerships with a variety of interests:
- Public and private donors
- Pharmaceutical companies
- Scientific research organizations
- Global policymakers
- Non-governmental and international organizations
What is the International Partnership for Microbicides (IPM)?
IPM is a nonprofit product development partnership established in 2002 dedicated to developing new HIV prevention technologies and making them available to women in developing countries. IPM has offices in the United States, South Africa and Belgium.
What is the state of microbicide development?
Microbicides have been proven affective in the CAPRISA 004 study, which found a 39 percent lower HIV infection rate in women using 1% tenofovir gel as compared to those women using a universal placebo gel. Another multi-center trial will be needed to confirm the effectiveness of tenofovir. It is essential to develop a number of safe and effective microbicides that attack HIV at different points in its life cycle and that provide a choice of easy-to-use protection options for women. To this end, dozens of next-generation microbicide candidates are in safety studies and preclinical development, and some are in the beginning stages of efficacy trials.
What resources are needed to develop a microbicide in the next five to ten years?
Ongoing support is essential to the success of microbicide development. Funding must be secured before clinical trials can be conducted – and just a single efficacy trial alone can cost as much as $120 million. Between 2000 and 2007, global funding for microbicide research and development tripled, with the United States and European donors continually increasing support. There are signs though that support for microbicide research may be flattening. Between 2006 and 2007, the total investment in microbicide research increased 2 percent to US$226.5 million. Such funding levels are well below the annual $280 million amount recommended by microbicide experts to ensure an optimal research effort.
When will women have safe and effective microbicides?
With proper funding and political commitment, it could be possible to put microbicides into the hands of women in the next five to ten years.
Where are trials conducted?
IPM clinical trials and incidence studies are currently conducted in a number of countries in sub-Saharan Africa as well as in Belgium and the United States.
Who funds IPM?
IPM has received generous funding support from the governments of Belgium, Canada, Denmark, France, Germany, Ireland, the Netherlands, Norway, Sweden, Spain, the United Kingdom and the United States, as well as the Bill & Melinda Gates and Rockefeller Foundations, the European Commission, UNFPA and the World Bank.
Why do women need microbicides?
Increasingly, women and girls bear the brunt of the HIV/AIDS epidemic. The disease is now considered the leading cause of death for women worldwide between the ages of 15 and 50. More than 15.7 million women are currently living with HIV/AIDS globally, and the number continues to rise. In sub-Saharan Africa, nearly 60 percent of adults living with HIV are women. In some countries, HIV prevalence is three times higher among women ages 15 to 24 than it is among men in that same age group.
Women are becoming infected with HIV at a faster rate than men largely because of a combination of their increased cultural and biological vulnerability. Many women have little or no control over the conditions under which they have sex. They often cannot negotiate the use of condoms. A microbicide will give women the power of protection from HIV infection and save millions of lives.