Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women.
OBJECTIVE
To evaluate once or twice daily vaginal exposure to 2 and 4% PRO 2000 Gel, a naphthalene sulfonate polymer microbicide, in sexually active HIV-uninfected women to determine the highest tolerated frequency and concentration combination, and to assess this in sexually abstinent HIV-infected women.


METHODS
Sixty three women from Providence, Philadelphia, Durban and Johannesburg were enrolled after being screened to exclude pre-existing illnesses and were instructed to use the product once or twice daily for 14 intermenstrual days. They underwent colposcopy prior to product use and after 14 days of product use, with a pelvic examination at day 7.


RESULTS
The product was well tolerated, with no serious adverse events, even though 73% of the participants had at least one adverse experience: 82% of these were classified as mild, and over 90% of the findings and symptoms were localized to the genital tract. Women who used the 4% gel twice daily tended to have more adverse events than all the other groups. Three participants did not complete the study; one because of Herpes simplex virus cervicitis, the second because of epithelial disruption, and the third because she became pregnant. The remaining participants adhered to the study protocol and indicated that they would use the product if it were shown to be effective.


CONCLUSIONS
PRO 2000 Gel was safe and well tolerated in sexually active HIV-uninfected and sexually abstinent HIV-infected women, enabling the product to be considered for evaluation in efficacy trials.
Mayer
Kenneth H
KH
Infectious Disease Division, Miriam Hospital, 164 Summit Avenue, Providence, RI 02906, USA.
Karim
Salim Abdool
SA
Kelly
Clifton
C
Maslankowski
Lisa
L
Rees
Helen
H
Profy
Albert T
AT
Day
Jennifer
J
Welch
Julie
J
Rosenberg
Zeda
Z
D000282:Administration, Intravaginal; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015331:Cohort Studies; D004341:Drug Evaluation; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D020714:Maximum Tolerated Dose; D009282:Naphthalenesulfonates / Q000008:administration & dosage / Q000009:adverse effects*; D011108:Polymers / Q000008:administration & dosage / Q000009:adverse effects*; D012725:Sexual Behavior; D014622:Vaginal Creams, Foams, and Jellies
D000890:Anti-Infective Agents; D005782:Gels; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers; D014622:Vaginal Creams, Foams, and Jellies