Source:
J Acquir Immune Defic Syndr. 2003 Aug 1;33(4):476-483
Authors:
Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti AS, Profy AT, Moench TR,
Soto-Torres LE, Poindexter III AN, Frezieres RG, Walsh TL, Kelly CW,
Richardson BA, Van Damme L, Celum CL
Abstract:
OBJECTIVES
To assess safety and acceptability of penile application
of
BufferGel (ReProtect, Baltimore, MD) and PRO 2000 Gel (Indevus
Pharmaceuticals, Lexington, MA)compared with placebo among low-risk
sexually abstinent men and HIV-positive sexually abstinent men.DESIGN
Seventy-two healthy low-risk men (36 uncircumcised) and 25 HIV-positive
men (12 uncircumcised) were enrolled in 3 double-blind, single-center
studies as follows: 36 low-risk men in a study of BufferGel and K-Y Jelly
(McNeil-PPC, Skillman, NJ) placebo; 36 low-risk men in a study of PRO 2000
Gel and vehicle placebo; and 25 HIV-positive men in a crossover study of
BufferGel, PRO 2000 Gel, and K-Y Jelly placebo.
METHODS
Participants
applied product to the penis on 7 consecutive nights, kept study diaries,
and were then interviewed and examined. Urine was tested for inflammation
by leukocyte esterase.
RESULTS
No serious adverse events (AEs) or urethral
inflammation was detected. During use of BufferGel, 3 low-risk men (13%)
reported 6 AEs and 2 HIV-positive men (8%) reported 3 AEs. During use of
PRO 2000 Gel, 4 low-risk men (17%) reported 6 AEs and 1 HIV-positive
participant (4%) had 1 AE. AE rates during use of BufferGel and PRO 2000
Gel use were not significantly different from rates observed during
placebo. One low-risk man (4%) would object to his partners using
BufferGel and 3 (13%) to PRO 2000 Gel. Two HIV-positive men (8%) reported
they would object to partners using either BufferGel or PRO 2000
Gel.
CONCLUSIONS
Daily application of BufferGel and PRO 2000 Gel
directly
to the penis consecutively for 7 days was generally safe and well
tolerated among healthy low-risk men and HIV-positive men. These
microbicides have acceptable safety profiles to proceed with planned phase
3 vaginal microbicide trials.
