| Eligibility |
Inclusion Criteria:
1. Age 18 through 45 years (inclusive) at screening
2. Able and willing to provide written informed consent to be screened for and enrolled
in the study
3. Able and willing to provide adequate locator information at screening
4. HIV-uninfected based on testing performed by study staff at
5. In general good health as determined by the site clinician
6. Agree to abstain from any vaginal insertions, including products, douches, devices
such as sex toys, or penile or oral intercourse from 5 days prior to Visit 2
(Enrollment Visit) until the final Study Visit (one week after last dose of study
film). Only tampons during menses and clinically indicated speculum exams are allowed.
7. Agree to use condoms provided by the study staff from one week after last use of study
film until three weeks after last use of study film
8. Willingness to undergo all study-related assessments and follow all study-related
procedures
9. Be currently using an effective method of contraception at enrollment (used
continuously and with good compliance for the past 60 days as determined by
participant self-report) with plans to continue use throughout the study period.
Acceptable methods include any hormonal method (except vaginal ring); intrauterine
device (IUD) inserted at least 90 days prior to enrollment; female sterilization;
abstinent from sexual activity with male partner for the past 60 days; sexual activity
with vasectomized partner; engages in sex exclusively with women.
10. For participants 21 and older, a Pap result in the 36 calendar months prior to the
Enrollment Visit consistent with Grade 0 according to the Female Genital Grading Table
for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and
Pediatric Adverse Events satisfactory evaluation with no treatment required of
non-Grade 0 Pap result per American Society for Colposcopy and Cervical Pathology
(ASCCP) guidelines or per local standard of care, within the last 36 calendar months
prior to enrollment. Note: For participants aged 18-21, a Grade-0 or adequately
evaluated abnormal Pap smear is not required as the American Society for Colposcopy
and Cervical Pathology recommends initiating screening at age 21.
11. At screening and enrollment, agrees not to participate in other research studies
involving drugs, medical devices, or vaginal products while enrolled in this trial -
Exclusion Criteria:
1. Menopausal at screening (as defined as amenorrhea or irregular periods for one year or
more without an alternative etiology)
2. Hysterectomy
3. Known adverse reaction to any of the study products (ever)
4. Known adverse reaction to latex (ever)
5. Non-therapeutic injection drug use in the 12 months prior to screening
6. Surgical procedure involving the pelvis in the 90 days prior to screening (includes
dilation and curettage or evacuation, and cryosurgery; does not include cervical
biopsy for evaluation of an abnormal pap smear or IUD placement)
7. Participation in a drug, spermicide and/or microbicide study in the 30 days prior to
screening or anticipated participation in an investigational drug study in the next 8
weeks
8. Pregnancy within 90 days prior to screening
9. Lactating
10. Use of a diaphragm, NuvaRing®, or spermicide for contraception
11. As determined by the PI, a degree of menstrual cycle irregularity that would make it
difficult to schedule follow up visits without interruption by menses
12. Active sexually transmitted infection or documented treatment of sexually transmitted
infections in the last 6 months, including, but not limited to: chlamydia, gonorrhea,
syphilis, trichomonas, cervicitis or pelvic inflammatory disease, or currently active
HSV lesions or other sores. (Participants seropositive for or with a history of HSV
without current active lesions will not be excluded.)
13. Women who by history engage in condom-less intercourse with HIV-infected partners, or
who exchange sex for money, shelter, or gifts, or who in the opinion of the
investigators, may be at risk for HIV acquisition during the duration of the study
14. More than one sex partner within the past 3 months
15. Current sexual partner known by participant to be HIV seropositive
16. Current or planned use of pre-exposure prophylaxis against HIV infection
17. Currently active genital HSV lesions, or other genital tract epithelial disruption or
inflammation
18. Current or episodic use of anti-herpes suppressive therapy
19. Urinary tract infection, symptomatic candidiasis, or symptomatic bacterial vaginosis
within 14 days of enrollment, or currently residual symptoms thereof Note: women with
these infections at screening can be enrolled after treatment and resolution of the
infection.
20. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
21. Use of systemic immunomodulatory medications within 4 weeks of enrollment
22. Menses or other vaginal bleeding at the time of enrollment* or expecting menses in the
10 days after enrollment (Segment A participants) or 16 days after enrollment (for
Segment B participants)
*Note: for women with monthly cycles, every attempt will be made to enroll these
participants in the first half of their menstrual cycle. Women who have vaginal
bleeding at the scheduled Enrollment Visit may return at a different date to be
re-examined and possibly enrolled provided they are still within the screening window
and meet all criteria.
23. Lack of stable living conditions to allow reliable room temperature storage of study
product (Segment B participants only)
24. At enrollment has any of the following laboratory abnormalities per the Division of
AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events,
Version 2.0, Nov 2014:
- Grade 1 or higher AST (aspartate aminotransferase) or ALT (alanine
aminotransferase)
- Grade 1 or higher creatinine
- Grade 2 or higher hemoglobin
- Grade 1 or higher platelets Note: otherwise eligible participants with an
exclusionary test may be re-tested once during the screening process.
25. As determined by the Principal Investigator (PI), any subject who has any significant
uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic,
gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or
infectious disease, anticoagulation with warfarin or heparin; or any other condition
that, in the opinion of the Investigator, would preclude provision of consent, make
participation in the study unsafe, complicate interpretation of study outcome data, or
otherwise interfere with achieving the study objectives.
|
