62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides

• Self-reported urethral pain, urethral burning, penile itching, penile rash, penile blisters, penile ulceration or penile discharge. [ Time Frame: At follow-up clinic visits on days 7, 14, 28, 35, 42 or 56. ] [ Designated as safety issue: Yes ]
  
• Adverse events other than those listed as primary endpoints judged related to product use. [ Time Frame: Varies ] [ Designated as safety issue: Yes ]
  

• Reported positive attributes or negative attributes of the study products, willingness to use and recommend the products, adherence with use of condoms and of the topical microbicide. [ Time Frame: Varies ] [ Designated as safety issue: No ]
  

In Kenya, the HIV/AIDS epidemic has significantly increased adult and child mortality. Current prevention options, including the ABC model (Abstinence, Be faithful and correct and consistent Condom use) have not been sufficient to curb the generalized HIV epidemic. The development of topical microbicides provides a potential new prevention option against sexually transmitted infections (STIs), including HIV. Despite widespread use of topical microbicides among U.S. servicemen during World Wars I & II to prevent STI, the current HIV agenda has thus far focused almost exclusively on microbicide research for intravaginal use by females. Research on use of topical microbicides on the male genitalia has only examined potential adverse effects on the penis of microbicides intended for intravaginal or rectal use. Further research is necessary to determine what formulations, what doses, and what types of topical antimicrobials might prove acceptable, and tolerable for external genital use by male sub-populations, and effective for preventing HIV/STI in men. This Phase 1 safety trial is the culmination of a stepwise series of studies examining male genital hygiene and safety and acceptance of an alcohol-based topical microbicide among Kenyan men. The purpose of this randomized, double-blinded, placebo-controlled, crossover trial is to assess the safety and acceptability of 62% ethanol in emollient gel (intervention) and 15% ethanol in emollient gel (placebo), applied to the penis by men each morning and after every sexual exposure. The study population will include 30 healthy, uncircumcised Kenyan men working in the fishing industry. Participants will be randomly assigned to initial use of 1 of the 2 products for a 2-week interval. After a subsequent 2-week wash out period in which no topical gel will be used, the men will then cross over to use of the second product. The primary study objective is to assess the safety and toxicity of 62% and 15% ethanol in emollient gel on the penile epithelium and urethral mucosa. The secondary study objective is to assess the acceptability and compliance with the topical microbicide (62% ethanol) and placebo (15% ethanol) by men each morning and after each act of sexual intercourse. The primary study outcome measures include: self-reported urethral pain, urethral burning, penile itching, penile rash, penile blisters, penile ulceration or penile discharge at follow-up clinic visits on days 7, 14, 28, 35, 42 or 56; erythema (with or without induration), vesiculation, bullous reaction, and ulceration, of the penile shaft, foreskin, and glans, as observed by visual exam at follow-up clinic visits on days 7, 14, 28, 35, 42, or 56; erythema or ulceration of the urethral meatus, as observed by visual exam at follow-up clinic visits on days 7, 14, 28, 35, 42 or 56; and adverse events other than those listed as primary endpoints judged related to product use. The secondary study outcome measures are reported positive attributes (ease of use, increased pleasure during sex, positive feedback from primary sex partner) or negative attributes (difficulty of use, decreased pleasure during sex, negative feedback from primary sex partner) of the study products; reported willingness to use and recommend the products; and reported adherence with use of condoms and of the topical microbicide. Each participant will take part in the study for up to 8 weeks, including the screening period. The entire study should be completed within 5-6 months.