title: Safety and acceptability of penile application of 2 candidate topical microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk men and HIV-positive men.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA 98104, USA. stabet@u.washington.edu
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Tabet
authors.forename: Marianne M
authors.initials: MM
authors.lastname: Callahan
authors.forename: Christine K
authors.initials: CK
authors.lastname: Mauck
authors.forename: Fang
authors.initials: F
authors.lastname: Gai
authors.forename: Anne S
authors.initials: AS
authors.lastname: Coletti
authors.forename: Albert T
authors.initials: AT
authors.lastname: Profy
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Moench
authors.forename: Lydia E
authors.initials: LE
authors.lastname: Soto-Torres
authors.forename: Alfred N
authors.initials: AN
authors.lastname: Poindexter III
authors.forename: Ron G
authors.initials: RG
authors.lastname: Frezieres
authors.forename: Terri L
authors.initials: TL
authors.lastname: Walsh
authors.forename: Clifton W
authors.initials: CW
authors.lastname: Kelly
authors.forename: Barbra A
authors.initials: BA
authors.lastname: Richardson
authors.forename: Lut
authors.initials: L
authors.lastname: Van Damme
authors.forename: Constance L
authors.initials: CL
authors.lastname: Celum
mesh_terms: D000180:Acrylic Resins; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009282:Naphthalenesulfonates / Q000008:administration & dosage* / Q000009:adverse effects; D011108:Polymers / Q000008:administration & dosage* / Q000009:adverse effects; D013089:Spermatocidal Agents / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000180:Acrylic Resins; C420918:BufferGel; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers; D013089:Spermatocidal Agents