Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females

Inclusion Criteria:

- Age 15 through 17 years, inclusive, as per site policy

- General good health (by volunteer history and per investigator discretion) without
any clinically significant systemic disease (including, but not limited to
significant liver disease/hepatitis, gastrointestinal disease, kidney disease,
thyroid disease, osteoporosis or bone disease, and diabetes)

- Able to communicate in spoken and written English

- Willing to following instructions regarding vaginal activity and vaginal products as
follows:

1. Willing to abstain from all vaginal activity, including intercourse, for 48
hours prior to Visit 2 and 48 hours prior to Visit 7

2. Willing to abstain from the use of vaginal products other than the study product
including spermicides, lubricants, and douches for the duration of study
participation.

Note: Tampons may be used for menses, but pads should be used for any other intermenstrual
spotting or bleeding.

- Assessment of onset and progression of puberty as measured by Tanner Stage 4 or 5

- History of consensual penile-vaginal intercourse (at least one episode in
participant's lifetime)

- Negative urine pregnancy test

- Use of an effective method of contraception for at least the past 30 days (per
participant report) and intended use for the duration of study participation.
Effective methods include:

1. Hormonal methods (excluding contraceptive ring)

2. Intrauterine contraception (IUC)

Note: An IUC must be in place for at least 15 days prior to enrollment

- Willing to give voluntary assent, and comply with study procedures as required by the
protocol assent and willing for parent/guardian to provide written informed consent
for participation as per Institutional Review Board (IRB) requirements. Emancipated
minors may give their own informed consent.

Exclusion Criteria:

- Known adverse reaction to study products (ever) or latex, per participant report

- Non-therapeutic injection drug use in the last 12 calendar months

- Post-exposure prophylaxis (PEP) for HIV-1 exposure within the last 6 calendar months

- Currently pregnant or within 30 days from the last pregnancy outcome.

Note: If recently pregnant must have had at least two spontaneous menses since pregnancy
outcome.

- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days

- Intention to become pregnant in the next 6 months

- Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study

- Positive for HIV

- Grade 2 or higher as per the Division of AIDS (DAIDS) Table for Grading Adult and
Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August
2009) of the following:

1. Alanine transaminase (ALT), aspartate aminotransferase (AST)

2. Creatinine

3. Hemoglobin

4. Platelet count

5. Hepatitis B surface antigen (HBsAg)

Note: Otherwise eligible participants with an exclusionary test result(s) listed above may
be re-tested a maximum of one time and if a non-exclusionary result is documented within
the 30 days of providing informed consent, they may be enrolled.

- Clinically apparent Grade 2 or higher pelvic examination finding (observed by study
staff) per the Female Genital Grading Table for Use in Microbicide Studies (Addendum
1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0,
December 2004 (Clarification dated August 2009)

Note: 1) Cervical bleeding associated with speculum insertion and/or specimen collection
judged to be within the range of normal according to the clinical judgment of the
Principal Investigator/designee is considered expected non-menstrual bleeding and is not
exclusionary. 2) Otherwise eligible participants with exclusionary pelvic examination
findings may be enrolled /randomized if improvement of findings to a non-exclusionary
grade or to resolution can be documented within 30 days of providing informed consent for
Screening.

- Current pelvic inflammatory disease (PID) or sexually transmitted infection requiring
treatment per current Centers for Disease Control and Prevention (CDC) guidelines
(e.g., Trichomonas vaginalis, Neisseria gonorrhea (GC), Chlamydia trachomatis (CT),
or active herpes outbreak)

- Symptomatic vulvovaginal candidiasis, symptomatic bacterial vaginosis (BV) or urinary
tract infection (UTI)

Note: Otherwise eligible participants with symptomatic vulvovaginal candidiasis, BV or UTI
prior to genital sampling at Visit 2 will be offered treatment and may be continue in the
study after completing treatment and all symptoms and findings have resolved.

- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, antifungals, antivirals (e.g., acyclovir or
valacyclovir) or antiretrovirals (e.g., Viread®, Atripla®, Emtriva®, Complera®,
Stribild®).

Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) except for
treatment of dysmenorrhea during menses. Participants may use Tylenol® on an as-needed
but not daily basis during the study.

- Participation in any other investigational trial (device, drug, or vaginal trial)
within the last 30 days or planned participation in any other investigational trial
during the study

- Any other condition that, in the opinion of the Principal Investigator (PI) or
designee, would preclude informed consent, make study participation unsafe,
complicate interpretation of study outcome data, or otherwise interfere with
achieving the study objectives