HPTN 032

Male Tolerance Study of BufferGel and PRO 2000/5 Gel (P)

Study Summary

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