Population Council Projects | Clinical Studies: Carraguard® Phase 3 Efficacy Trial

PROJECT
Clinical Studies: Carraguard® Phase 3 Clinical Trial

The Phase 3 clinical trial of the Population Council’s candidate microbicide Carraguard did not demonstrate that Carraguard is effective in preventing male-to-female HIV transmission during vaginal intercourse. Carraguard was shown to be safe for use during vaginal sex over a two-year period. This finding is important because Carraguard is an ingredient of next-generation microbicide candidates being developed at the Council. Several of these candidates combine Carraguard with one or more ingredients that have been shown to be effective in preventing virus transmission in laboratory settings. Carraguard is the first candidate microbicide to have completed a Phase 3 trial without any safety concerns. (news release)

Data collection began in March 2004 and was completed in March 2007 at three sites in South Africa: the University of Cape Town in Gugulethu; the University of Limpopo/Medunsa campus in Soshanguve, near Pretoria; and the Medical Research Council (MRC) in Isipingo, near Durban.

The primary objectives of the trial were to determine the efficacy of Carraguard gel in preventing male-to-female transmission of HIV when applied prior to vaginal sex, and to evaluate its safety when used for up to two years. A total of 6,202 women enrolled, with each woman participating in the trial for a minimum of nine months and a maximum of two years.

After a comprehensive informed consent process involving a study booklet and video made specifically for the Carraguard trial, eligible, consenting women were randomized to one of two groups: Carraguard gel plus condoms or its matching placebo (methyl cellulose) plus condoms. Neither participants nor study staff knew which participants had which gel. Women were instructed to insert the study gel before each act of vaginal intercourse and to come to the clinic for quarterly pelvic exams, interviews about sexual behavior, safer-sex counseling, testing and treatment of curable sexually transmitted infections, and free condoms. Women also were counseled to use a condom with each sex act.

During the trial, members of the Carraguard trial's Data Safety Monitoring Board, an independent group of scientists, reviewed the data three times to ensure participants' safety and did not recommend stopping the trial for any reason.

Location

Gugulethu, Isipingo, and Soshanguve, South Africa

Duration

March 2004–March 2007

Population Council researchers

Barbara Friedland, Marlena Gehret, Sumen Govender, Pekka O. Lähteenmäki, Robin A. Maguire

Non-Council collaborators

Khatija Ahmed (University of Limpopo/Medunsa campus)

Lydia Altini (University of Cape Town)

Gita Ramjee (South African Medical Research Council)

Donors

Bill & Melinda Gates Foundation

US Agency for International Development

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

2007
Ramjee, Gita, Neetha S. Morar, Sarah Braunstein, Barbara Friedland, Heidi Jones, and Janneke van de Wijgert. "Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa," AIDS Research and Therapy 4: 20. (abstract)

van de Wijgert, Janneke H.H.M., Sarah Braunstein, Neetha S. Morar, Heidi Jones, Lorna Madurai, Tammy T. Evans Strickfaden, Manivasan Moodley, Jamila Aboobaker, Gugulethu Ndlovu, Taja M. Ferguson, Barbara A. Friedland, Clyde E. Hart, and Gita Ramjee. "Carraguard vaginal gel safety in HIV-positive women and men in South Africa," Journal of Acquired Immune Deficiency Syndromes 46(5): 538–546. (abstract)

2006
Skoler, Stephanie, Leigh Peterson, and Ward Cates. "Our current microbicide trials: Lessons learned and to be learned," Microbicide Quarterly 4(1): 1–6. (PDF)

2005
Skoler, Stephanie, Sumen Govender, Lydia Altini, Khatija Ahmed, Donald Waldron, Landon Myer, and Pekka Lähteenmäki. "Risks in the use of an unblinded control group (letter)," Journal of Infectious Diseases 191(8): 1378–1379.

van de Wijgert, Janneke, Heidi Jones, Annalie Pistorius, Alana de Kock, Mohlatlego Sebola, Barbara Friedland, Anwar Hoosen, and Nicol Coetzee. "Phase III microbicide trial methodology: Opinions of experienced expanded safety trial participants in South Africa," Journal of Social Aspects of HIV/AIDS 2(3): 311–319. (abstract) (résumé en français)

Related Projects