Open AccessPreclinical Safety and Efficacy Assessments of Dendrimer-Based (SPL7013) Microbicide Gel Formulations in a Nonhuman Primate Model
Author(s) -
Dorothy L. Patton,
Yvonne T. Cosgrove Sweeney,
Tom D. McCarthy,
Sharon L. Hillier
Publication year - 2006
Publication title -
antimicrobial agents and chemotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.07
H-Index - 259
eISSN - 1070-6283
pISSN - 0066-4804
DOI - 10.1128/aac.50.5.1696-1700.2006
Subject(s) - microbicide , dendrimer , intravaginal administration , chlamydia trachomatis , microbicides for sexually transmitted diseases , herpes simplex virus , vaginal microbicide , medicine , sexually transmitted disease , virology , pharmacology , human immunodeficiency virus (hiv) , virus , biology , vagina , surgery , population , biochemistry , syphilis , environmental health , health services
Three gel formulations (1%, 3%, and 5% [wt/wt]) of SPL7013, a dendrimer known to have antiviral (anti-human immunodeficiency virus and anti-herpes simplex virus) activities, completed a range of preclinical tests in the pigtailed macaque models for vaginally and rectally applied topical microbicide safety assessments. The vaginal safety profile of the 3% SPL7013 gel formulation was equal to that of the 1% formulation but was superior to that of the 5% formulation. The 3% SPL7013 gel was further evaluated for rectal safety and for antichlamydial efficacy with cervical challenge withChlamydia trachomatis . This first-generation dendrimer-based product was shown to be safe to the vaginal and rectal microenvironments with repeated daily use. However, a single intravaginal application of the 3% (wt/wt) SPL7013 gel did not provide protection from the acquisition of cervical chlamydial infection.