Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)
What is HPTN 032?
HPTN 032 is an HIV prevention trial involving HIV-positive men in the Seattle, WA area. The study's purpose is to assess the toxicity and acceptability of a topical microbicide when applied to the penis of HIV-infected men. This kind of assessment is important in determining the future viability of similar products in preventing the transmission of HIV.
The study has completed enrollment, follow-up, and data analysis. Results demonstrated that the daily application of the study's topical microbicide products directly to the penis consecutively for 7 days was generally safe and well tolerated among men participating in the study.
Protocol Status: Concluded
Study Purpose: To assess the toxicity and acceptability of BufferGel and PRO 2000/5 Gel (P) when applied to the penis of HIV-infected men, compared to a placebo control gel.
Study Design: Phase I, randomized, blinded, crossover study with one week of exposure to each of BufferGel, PRO 2000 Gel (P), and a placebo control gel. Each week of exposure is separated by a one-week washout period.
Study Population: Circumcised and uncircumcised HIV-infected men residing in the Seattle, WA area.
Study Size: 24 participants total (12 circumcised, 12 uncircumcised)
Study Duration: Approximately eight months total. Accrual required six-and-a-half months and each participant is followed for a minimum of five weeks.
Treatment Regimen: Nightly application of 2 mL of BufferGel, PRO 2000/5 Gel (P), or placebo gel for a period of seven consecutive nights each. Gel is applied to the shaft and glans of the penis at bedtime, left on for a minimum of six hours, and washed off the next morning.
Primary Objectives: To assess the toxicity of BufferGel and PRO 2000/5 Gel (P) on the penile epithelium and urethral mucosa of HIV-infected men.
Secondary Objectives: To assess the acceptability of BufferGel and PRO 2000/5 Gel (P) among HIV-infected men.
HPTN 032 Publication
Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti AS, Profy AT, Moench TR, Soto-Torres LE, Poindexter AN, Frezieres RG, Walsh TL, Kelly CW, Richardson BA, van Damme L, Celum CL. 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. J Acquir Immune Defic Syndr. 2003, 33: 476-83