Population Council Projects | Clinical Studies: Carraguard® Phase 2 Expanded Safety and Acceptability Trials

PROJECT
Clinical Studies: Carraguard® Phase 2 Expanded Safety and Acceptability Trials

After a Phase 1 safety trial ensures through a small number of healthy volunteers that a product does not cause harm in people, an expanded, Phase 2 trial is conducted.

Refinement of the carrageenan gel in the laboratory after testing PC-503 and PC-213 (see "Clinical Studies: Carraguard® and Other Phase 1 Safety Trials") led to an even more promising formulation of lambda- and kappa-carrageenan, PC-515 or Carraguard.

The Council, with collaborators in South Africa and Thailand, tested this new formulation in two expanded safety and acceptability trials between October 1999 and November 2001. The countries were chosen based on their rates of HIV infection. In 2001, an estimated four million South Africans, approximately 10 percent of the population, were infected with HIV. This was one of the highest infection rates in the world. Although not as high as South Africa's, at the time the trials were conducted, rates of HIV infection in northern Thailand were also quite high. (Since this study took place, the number of new HIV infections per year in Thailand has declined dramatically.)

In South Africa, 400 women were enrolled at two trial sites. The Gugulethu location was managed by the University of Cape Town, and the site at Ga-Rankuwa, near Pretoria, was managed by the Medical University of Southern Africa (MEDUNSA). In Chiang Rai, Thailand, 165 women were enrolled at one site managed by the Thailand Ministry of Public Health–US Centers for Disease Control and Prevention (CDC) Collaboration.

Participants at all three sites were randomized to groups using Carraguard gel or its matching placebo, methyl cellulose gel, and neither participants nor staff knew which product they were receiving. Participants were instructed to insert the study gel at least three times a week (approximately every other day) and before each act of vaginal intercourse. Additionally, the women were instructed to use a condom during sex. Women returned to the clinic for monthly pelvic exams, interviews about compliance and acceptability, safer-sex counseling, testing and treatment of curable reproductive tract infections, and free condoms. Results showed that Carraguard does not cause significant irritation of the female reproductive tract and that the gel is acceptable to women when used three times a week and during vaginal intercourse.

Locations

Gugulethu and Ga-Rankuwa, South Africa, and Chiang Rai, Thailand

Duration

October 1999–November 2001

Publications/Resources
Council researchers' names appear in boldface type.

2004
Pistorius, Annalie, Janneke van de Wijgert, Mohlatlego Sebola, Barbara A. Friedland, Evelyn Nagel, Cathleen Bokaba, and Anwar Hoosen. "Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs," Journal of Social Aspects of HIV/AIDS 1(2): 78–86.* (abstract)

Kanokwan, Tharawan, Chomnad Manopaiboon, Charlotte Ellertson, Khanchit Limpakarnjaranat, Supaporn Chaikummao, Peter H. Kilmarx, Kelly Blanchard, Christiana Coggins, Timothy D. Mastro, and Christopher J. Elias. “Women’s willingness to participate in microbicide trials in northern Thailand,” Journal of Acquired Immune Deficiency Syndromes 28(2): 180–186.* (abstract)

* Not available from the Population Council.

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