Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)
What was HPTN 032?
A Phase I, randomized, blinded, crossover study to assess the toxicity and acceptability of a topical microbicide when applied to the penis of HIV-infected men.
Who participated in the study?
12 circumcised and 12 uncircumcised HIV-infected men residing in the Seattle, WA area.
What happened during the study?
Nightly application of 2 mL of BufferGel, PRO 2000/5 Gel (P), or placebo gel for a period of seven consecutive nights each. Gel was 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.
Results
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.
Study Documents
Study Details
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.
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.
Circumcised and uncircumcised HIV-infected men residing in the Seattle, WA area.
24 participants total (12 circumcised, 12 uncircumcised)
Approximately eight months total. Accrual required six-and-a-half months and each participant is followed for a minimum of five weeks.
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.
To assess the toxicity of BufferGel and PRO 2000/5 Gel (P) on the penile epithelium and urethral mucosa of HIV-infected men.
To assess the acceptability of BufferGel and PRO 2000/5 Gel (P) among HIV-infected men.