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