Results

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

Stephen R. Tabet, Marianne M. Callahan, Christine K. Mauck, Fang Gai, Anne S. Coletti, Albert T. Profy, Thomas R. Moench, Lydia E. Soto-Torres, Alfred N. Poindexter III, Ron G. Frezieres, Terri L. Walsh, et al. Journal of Acquired Immune Deficiency Syndromes 2003 33(4): 476-483

Objectives: To assess safety and acceptability of penile application of BufferGel 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 placego; 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.

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