Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

Inclusion criteria

• At least 18 years of age at Screening, verified per site standard operating procedure (SOP)
• Able and willing to provide written informed consent to be screened for and take part in the study
• At Screening, able and willing to provide adequate locator information, as defined per site SOP
• Able and willing to communicate in written and spoken English
• HIV-uninfected at Screening per Algorithm in Appendix II
• In general good health, according to the clinical judgment of the Investigator of Record (IoR) or designee
• Willing to abstain from vaginal, oral and anal intercourse (including receptive anal intercourse), even with a condom; masturbation, and other activities that may cause irritation or injury to the penis during study participation
• Willing to abstain from using any genitally-applied preparations (except use of usual cleansing products for genital hygiene) other than the study product during study participation
• Willing to abstain from non-urgent surgical procedures of the penis/GU area for the duration of study participation (e.g. circumcision)
• At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, or genital products for the duration of study participation (until all follow-up visits are completed)

Exclusion criteria

• Participant report of any of the following:

• Known adverse reaction to any of the study products or components of the study products (ever)
• Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to Enrollment
• Penile procedures (e.g. biopsy, circumcision) within 42 days or less prior to Enrollment
• Participation in any other research study involving drugs, medical devices, or genital products within 30 days or less prior to Enrollment
• Within the three months prior to Enrollment, history of a non-gonococcal urethritis and/or sexually transmitted infection (STI), including outbreak of genital herpes or condylomata
• For uncircumcised men, the treatment of candidal balanoposthitis/ balanitis within 30 days prior to Enrollment
• History of recurrent dermatosis (e.g. eczema)
• Non-therapeutic injection drug use in the 12 months prior to Screening
• Currently using an immunosuppressant (with the exception of local nongenital use of low potency products e.g. inhaled corticosteroid for asthma)
• Has any of the following laboratory abnormalities at Screening:

• Hemoglobin < 10.0 g/dL
• Platelet count < 100,000/mm3
• White blood cell count < 2,000 cells/mm3
• Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5x the site laboratory upper limit of normal (ULN)
• Serum creatinine > 1.3x the site laboratory ULN
• Calculated creatinine clearance less than 80 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140-age in years) x (weight in kg) x 0.85/72 x serum creatinine in mg/dL Note: Otherwise eligible participants with any of the above exclusionary laboratory results may be re-tested. If a participant is re-tested and a non exclusionary result is documented within 30 days of providing informed consent for Screening, the participant may be enrolled.
• At Screening or Enrollment, diagnosed with STI or reproductive tract infection (RTI) requiring treatment, per current Centers for Disease Control and Prevention (CDC) guidelines
• At Screening or Enrollment, has a clinically apparent Grade 1 or higher genital exam finding (observed by study staff)
• At Screening or Enrollment, has Grade 1 or higher genital or urinary symptoms
• At Screening or Enrollment, diagnosed with phimosis or hypospadias
• At Screening or Enrollment, penile, scrotal piercing or penile tattoos observed during genital examination
• Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives