Project

Developing an ARV-Based Microbicide Gel

The Population Council is developing a microbicide gel to prevent the transmission of HIV and other sexually transmitted infections.

The Issue

Worldwide, millions of individuals are newly infected with HIV each year, underscoring the urgent need for new HIV prevention methods. While male and female condoms are effective when used correctly, they are not practical for men and women who cannot negotiate condom use and for women and couples who want to have children.

The Population Council is developing new, user-controlled prevention methods called microbicides that protect against HIV and other STIs. An antiretroviral-based microbicide gel currently under development contains two effective antiviral agents—MIV-150, an enzyme inhibitor that prevents HIV-infected cells from producing new virus, and zinc acetate, an antiviral agent with activity against HIV and herpes simplex virus (HSV)—in a base of carrageenan, a compound derived from seaweed that has broad-spectrum antiviral properties. The gel, known as MZC, may prevent the acquisition and transmission of HIV and other STIs, such as HSV-2 and human papillomavirus (HPV).

The Progress

Council researchers and our collaborators have tested the safety and efficacy of the MZC gel in in vitro (in cells and tissues) and in vivo (in animals) studies. They have shown that the MZC gel completely blocked vaginal simian immunodeficiency virus (SIV) infection in monkeys for up to 8 hours after gel application and reduced rectal SIV infection when applied 1 hour prior to challenge. The MZC gel also effectively blocked vaginal and rectal HSV-2 and HPV infection in mice and vaginal HSV-2 infection in macaques.

On the basis of the safety and efficacy of the MZC gel in animal studies, the Population Council is testing the gel in a Phase 1 clinical trial in women. The trial will determine the safety of the gel after vaginal administration, as well as the levels of MIV-150 and zinc acetate in the blood of trial participants at different times after they use the gel.

The Impact

The Council has been a leader in the research and development of gel-based microbicides since 1994. If proven safe and effective, next-generation microbicides such as the MZC gel have the potential to allow millions of women and men to protect themselves from HIV and other STIs and to improve global health. 

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