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PROJECT
Nonclinical Laboratory Studies: PC-710
(Carraguard®
with Zinc)
Laboratory scientists at the Population Council's Center for Biomedical Research are developing several second-generation formulations based on the Council's lead first-generation microbicide candidate, Carraguard.
PC-710, which combines zinc with Carraguard, may offer protection against sexually transmitted infections beyond what has been observed with Carraguard alone. Carraguard’s safety, activity, and quality have all been proven in extensive nonclinical testing.
In laboratory studies, zinc has been shown to prevent certain viruses in vitro, some of which include HIV-1, foot-and-mouth disease virus, human rhinovirus A-B, Semliki Forest virus, and Sindbis virus. Zinc is a naturally occurring element that is known to be necessary for good health and plays an important role in the immune system. The zinc used in PC-710 has been tested for homogeneity and stability over a six-month period.
Efficacy testing has indicated that PC-710’s activity against HIV-1 is slightly increased compared to Carraguard’s, but it is significantly more effective against herpes simple virus type 2 (HSV-2) in animal studies. PC-710 also has shown to be active post-virus exposure, which indicates that PC-710 may be used after unprotected sex (current microbicides must be used before sexual intercourse to be protective). PC-710 also shows increased activity, in comparison to Carraguard alone, against trichomoniasis, which is a sexually transmitted disease that may cause infertility and is a co-factor to HIV transmission.
Toxicological testing has established that PC-710 shows little to no toxicity to cells in culture.
Most recently, a study was conducted to test PC-710’s effect on vaginal epithelia in the rabbit. The results did not match the expected results, as the positive control, known to be a severe irritant, indicated little difference in irritation compared to the test substance. An error was noted in the study protocol, and the study currently is being repeated. A study also recently proved the effectiveness of the preservative in the PC-710 formulation.
Carraguard® is the Population Council's US trademark for pharmaceutical preparations, namely microbicides, for use in preventing infection.
Location
New York, New York
Duration
2000–present
Population Council researchers
David M. Phillips, Robin Maguire
Donor
National Institutes of Health
Related Projects, Nonclinical
Contact: microbicide@popcouncil.org
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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) Stay Informed |