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What Comes Next

Population Council biomedical scientists are continuing basic research on HIV transmission and are working on developing second-generation microbicide formulations that may be more effective against a broader range of sexually transmitted pathogens and/or have contraceptive properties.

If current or future trials prove successful, and one of the Council's candidate microbicides is shown to be safe and effective, additional steps will have to be taken before the product is available to consumers. Product approvals would have to be secured through the regulatory bodies of the countries in which the product would be marketed; and agreements would be needed for production and distribution.

All three of the clinical testing sites for the microbicide candidate Carraguard® were in South Africa, which has one of the highest HIV and AIDS prevalence rates in the world. The South African regulatory agency (the Medicines Control Council) approved the trial, which was coordinated in the Council's Johannesburg office.

The abundance of carrageenan—a naturally occurring substance derived from seaweed—should make it a low-cost ingredient, helping keep the product as inexpensive as possible.

Historically, the Population Council has developed safe, effective contraceptives and worked to make them available at very low (or no) cost to people in developing countries. (For instance, more than 76 million Copper T 380A IUDs have been distributed in over 70 countries, most at very nominal costs to the user.) The Council accomplishes this by including provisions for low-cost access to the products when licensing its contraceptive products to pharmaceutical companies for manufacture and marketing. Alternatively, a charitable foundation may be created to donate the product. Any agreement with a firm regarding microbicides would contain similar provisions, and any royalties that the Council would earn from the development of a successful microbicide would be reinvested into future public health research projects.

The Population Council is committed to working with funding organizations and international public health institutions—such as the World Bank, the United Nations, and the US Agency for International Development—to facilitate the accessibility and affordability of these products in the developing world. In fact, making microbicides available where they are most needed is a primary goal of the organization.

Carraguard® is the Population Council's US trademark for pharmaceutical preparations, namely microbicides, for use in preventing infection.


Project

See Also

Contact: microbicide@popcouncil.org



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This page updated
7 February 2008


   

What's New

Council selects Louise Pedneault clinical director, microbicides, HIV and AIDS program (more)

Presentations by Council researchers at the Microbicides 2008 conference in New Delhi are now available. (more)

"Disappointment in trials another lesson," 26 February 2008 op-ed from The Star, South Africa (posted with permission) (PDF)

The results of the Phase 3 Carraguard® trial have been announced. (more)

For fact sheets and other resources about the Carraguard trial, click here.

"Benefits of the Population Council's microbicides program and Phase 3 Carraguard trial" (2008) (PDFs: A4 and letter)

"Day of dialogue—Insights and evidence from product introduction: Lessons for microbicides" (2007) (PDF)

"Ethics in clinical trials: Population Council's microbicides program," describes the Council's efforts to ensure microbicide research is ethical and transparent. (PDF)

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Publications/Resources

"The Population Council, HIV and AIDS, and microbicides," a fact sheet for those seeking additional information about the Carraguard trials (full text) (PDF)

"Our current microbicide trials: Lessons learned and to be learned" (2006) (PDF)

More