Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites.
OBJECTIVE
To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial.


METHODS
HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator ( approximately 5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week.


RESULTS
In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis.


CONCLUSIONS
BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.
van De Wijgert
J
J
University of Zimbabwe-University of California San Francisco Women's Health Program, Harare, Zimbabwe. jvandewijgert@popcouncil.org
Fullem
A
A
Kelly
C
C
Mehendale
S
S
Rugpao
S
S
Kumwenda
N
N
Chirenje
Z
Z
Joshi
S
S
Taha
T
T
Padian
N
N
Bollinger
R
R
Nelson
K
K
D000180:Acrylic Resins; D000282:Administration, Intravaginal; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D015331:Cohort Studies; D003075:Coitus; D005260:Female; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007194:India; D008295:Malawi; D012746:Sexual Abstinence; D013089:Spermatocidal Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000494:pharmacology; D013785:Thailand; D014621:Vagina / Q000737:chemistry / Q000187:drug effects / Q000382:microbiology; D016585:Vaginosis, Bacterial / Q000188:drug therapy / Q000382:microbiology / Q000517:prevention & control; D015003:Yeasts / Q000187:drug effects / Q000302:isolation & purification; D015030:Zimbabwe
D000180:Acrylic Resins; D000891:Anti-Infective Agents, Local; C420918:BufferGel; D013089:Spermatocidal Agents