Safety and efficacy evaluations for vaginal and rectal use of BufferGel in the macaque model.
BACKGROUND
The nonhuman primate model allows for safety and efficacy testing of topical microbicide products.


OBJECTIVE
The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of BufferGel (ReProtect, Inc.).


METHODS
The safety of repeated product applications was evaluated by microflora, pH, vaginal colposcopy, and rectal lavage. To test efficacy in preventing chlamydia, infection was documented by culture and nucleic acid amplification tests.


RESULTS
Repeated vaginal or rectal applications of BufferGel were not associated with significant changes in microflora. BufferGel use had a transient acidifying effect on vaginal and rectal pH. Colposcopic observations remained relatively normal in all test animals. A slightly increased incidence of epithelial desquamation was noted after rectal product use compared with the control group. BufferGel did not prevent cervical or rectal chlamydial infection.


CONCLUSIONS
BufferGel has an acceptable safety profile after repeated vaginal and rectal use, but does not prevent chlamydial infection in the macaque models.
Patton
D L
DL
Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington 98195-6460, USA. dpatton@u.washington.edu
Sweeney
Y C
YC
Cummings
P K
PK
Meyn
L
L
Rabe
L K
LK
Hillier
S L
SL
D000180:Acrylic Resins; D000282:Administration, Intravaginal; D000285:Administration, Rectal; D000818:Animals; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002690:Chlamydia Infections / Q000517:prevention & control*; D002692:Chlamydia trachomatis; D005260:Female; D008254:Macaca nemestrina; D023421:Models, Animal; D012007:Rectum / Q000382:microbiology / Q000473:pathology; D013089:Spermatocidal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014621:Vagina / Q000382:microbiology / Q000473:pathology
D000180:Acrylic Resins; D000890:Anti-Infective Agents; C420918:BufferGel; D013089:Spermatocidal Agents