via the Population Council
Trial Showed Anti-HIV Microbicide Candidate Is Safe, but Did Not Prove It Effective
The Lancet will publish the results of the Phase 3 clinical trial of the microbicide candidate Carraguard® in its 6 December issue (available online on Friday 5 December). The Population Council sponsored the study at three sites in South Africa from 2004 to 2007. The trial evaluated the gel’s safety when used vaginally during a two-year period and assessed its efficacy for preventing male-to-female transmission of HIV.
The international, nonprofit research organization previously announced these results and informed trial participants, government officials, advocates, and other interested parties in February 2008 when the results were finalized.
Trial researchers found the product to be safe for vaginal use when used approximately once per week, on average, for up to two years. The trial did not demonstrate that Carraguard is effective in preventing male-to-female HIV transmission during vaginal intercourse.
Trial researchers found the product to be safe for vaginal use when used approximately once per week, on average, for up to two years. The trial did not demonstrate that Carraguard is effective in preventing male-to-female HIV transmission during vaginal intercourse.
Overview of Carraguard® Phase 3 Trial Findings
· The Phase 3 clinical trial of the Population Council’s candidate microbicide Carraguard did not show that Carraguard is effective in preventing HIV transmission during vaginal sex.
· Carraguard was found to be safe when used approximately once per week, on average, for up to two years, confirming results of previous safety trials.
· Carraguard’s favorable safety profile and physical properties make it a potentially useful vehicle for future generation microbicides.
· The safety of the participants in the Carraguard trials was the top priority of researchers and donors. More than 6,000 trial participants received high-quality sexual and reproductive health care and education free of charge, as well as regular testing and treatment for curable sexually transmitted infections (STIs), safer-sex counseling, HIV testing, and pelvic exams, all of which contribute to reduced risk of HIV infection.
Background
There were 134 new HIV infections in the Carraguard group (an incidence of 3.3 infections per 100 woman-years) and 151 new infections in a placebo group (an incidence of 3.8 per 100 woman-years). The difference between the two groups is not statistically significant.
The Carraguard trial, which began in March 2004 and ended in March 2007, enrolled 6,202 women and was conducted at three sites in South Africa: the Setshaba Research Centre, through the University of Limpopo, Medunsa campus; the Empilisweni Centre for Wellness Studies, through the University of Cape Town; and the Isipingo Clinic (near Durban), through the Medical Research Council of South Africa. These sites are located in areas where the HIV epidemic is acute.
Carraguard is made of carrageenan, a seaweed derivative that is on the US Food and Drug Administration’s list of products “Generally Recognized As Safe” for consumption and topical application. Laboratory research has shown Carraguard to be effective in blocking cells from becoming infected by HIV and human papillomavirus and in protecting mice from herpes simplex infections. Carraguard and similar carrageenan formulations had undergone extensive safety testing involving more than 850 women and men in earlier clinical trials in Australia, Chile, the Dominican Republic, Finland, South Africa, Thailand, and the United States.
Half of the women enrolled in the Phase 3 study were given Carraguard gel and condoms, and the other half received a placebo gel and condoms. Participants received HIV education, gynecological exams, risk-reduction and safer-sex counseling, and testing and treatment for curable sexually transmitted infections. The Population Council helped fund medical and psychological services for women who were HIV-positive at screening or who became HIV-positive during the course of the trial.
The randomized, double-blind study found that there were no differences between women using Carraguard and women using the placebo in terms of safety, and that gel-related side effects were minor and infrequent. The finding regarding safety and lack of side effects is important because Carraguard’s favorable safety profile and physical properties make it a potentially useful vehicle for future-generation microbicides to be developed at the Population Council.
The trial was funded by the US Agency for International Development (USAID) and the Bill & Melinda Gates Foundation. More information about the Population Council’s microbicides program is available at www.popcouncil.org/microbicides.
About the Population Council
The Population Council is an international, nonprofit, nongovernmental research organization that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Population Council has been working in Africa since the 1960s and in South Africa for nearly a decade. It has a global network of regional and country offices, including one in Johannesburg, South Africa, and ten others in Africa. During the past decade, the Council has worked on projects in 25 African countries.
About microbicides
The Lancet will publish the results of the Phase 3 clinical trial of the microbicide candidate Carraguard® in its 6 December issue (available online on Friday 5 December). The Population Council sponsored the study at three sites in South Africa from 2004 to 2007. The trial evaluated the gel’s safety when used vaginally during a two-year period and assessed its efficacy for preventing male-to-female transmission of HIV.
The international, nonprofit research organization previously announced these results and informed trial participants, government officials, advocates, and other interested parties in February 2008 when the results were finalized.
Trial researchers found the product to be safe for vaginal use when used approximately once per week, on average, for up to two years. The trial did not demonstrate that Carraguard is effective in preventing male-to-female HIV transmission during vaginal intercourse.
Trial researchers found the product to be safe for vaginal use when used approximately once per week, on average, for up to two years. The trial did not demonstrate that Carraguard is effective in preventing male-to-female HIV transmission during vaginal intercourse.
Overview of Carraguard® Phase 3 Trial Findings
· The Phase 3 clinical trial of the Population Council’s candidate microbicide Carraguard did not show that Carraguard is effective in preventing HIV transmission during vaginal sex.
· Carraguard was found to be safe when used approximately once per week, on average, for up to two years, confirming results of previous safety trials.
· Carraguard’s favorable safety profile and physical properties make it a potentially useful vehicle for future generation microbicides.
· The safety of the participants in the Carraguard trials was the top priority of researchers and donors. More than 6,000 trial participants received high-quality sexual and reproductive health care and education free of charge, as well as regular testing and treatment for curable sexually transmitted infections (STIs), safer-sex counseling, HIV testing, and pelvic exams, all of which contribute to reduced risk of HIV infection.
Background
There were 134 new HIV infections in the Carraguard group (an incidence of 3.3 infections per 100 woman-years) and 151 new infections in a placebo group (an incidence of 3.8 per 100 woman-years). The difference between the two groups is not statistically significant.
The Carraguard trial, which began in March 2004 and ended in March 2007, enrolled 6,202 women and was conducted at three sites in South Africa: the Setshaba Research Centre, through the University of Limpopo, Medunsa campus; the Empilisweni Centre for Wellness Studies, through the University of Cape Town; and the Isipingo Clinic (near Durban), through the Medical Research Council of South Africa. These sites are located in areas where the HIV epidemic is acute.
Carraguard is made of carrageenan, a seaweed derivative that is on the US Food and Drug Administration’s list of products “Generally Recognized As Safe” for consumption and topical application. Laboratory research has shown Carraguard to be effective in blocking cells from becoming infected by HIV and human papillomavirus and in protecting mice from herpes simplex infections. Carraguard and similar carrageenan formulations had undergone extensive safety testing involving more than 850 women and men in earlier clinical trials in Australia, Chile, the Dominican Republic, Finland, South Africa, Thailand, and the United States.
Half of the women enrolled in the Phase 3 study were given Carraguard gel and condoms, and the other half received a placebo gel and condoms. Participants received HIV education, gynecological exams, risk-reduction and safer-sex counseling, and testing and treatment for curable sexually transmitted infections. The Population Council helped fund medical and psychological services for women who were HIV-positive at screening or who became HIV-positive during the course of the trial.
The randomized, double-blind study found that there were no differences between women using Carraguard and women using the placebo in terms of safety, and that gel-related side effects were minor and infrequent. The finding regarding safety and lack of side effects is important because Carraguard’s favorable safety profile and physical properties make it a potentially useful vehicle for future-generation microbicides to be developed at the Population Council.
The trial was funded by the US Agency for International Development (USAID) and the Bill & Melinda Gates Foundation. More information about the Population Council’s microbicides program is available at www.popcouncil.org/microbicides.
About the Population Council
The Population Council is an international, nonprofit, nongovernmental research organization that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Population Council has been working in Africa since the 1960s and in South Africa for nearly a decade. It has a global network of regional and country offices, including one in Johannesburg, South Africa, and ten others in Africa. During the past decade, the Council has worked on projects in 25 African countries.
About microbicides
Vaginal microbicides are being developed primarily as female-initiated methods for reducing sexual transmission of HIV and possibly other sexually transmitted infections since, for many women worldwide, currently available prevention strategies are neither sufficient nor feasible. While no effective microbicides yet exist, research proceeds on a variety of scientific concepts; formulations such as gels, creams, and films; different delivery systems, for example vaginal rings and pre-loaded diaphragms; oral and rectal administration; and various dosing regimens. More information about microbicide research is available at the Global Campaign for Microbicides, at the IRMA website and at the Alliance for Microbicide Development.
An updated Carraguard Phase 3 trial Question and Answer document and statistics sheet are available here.
Barbara Friedland is the corresponding author on the Lancet article: bfriedland@popcouncil.org
An updated Carraguard Phase 3 trial Question and Answer document and statistics sheet are available here.
Barbara Friedland is the corresponding author on the Lancet article: bfriedland@popcouncil.org
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