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