Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Presence or absence of amelogenin
Study Overview
Brief Summary
The purpose of this study is to develop markers for use of placebo vaginal products and measure markers of mucosal semen exposure among healthy women. The study will also monitor safety of placebo product use.
Detailed Description
This is a Phase I, non-randomized, open label study in healthy, non-pregnant, HIV negative women, who are not at risk of pregnancy, and are at low risk for STIs (sexually transmitted infections). Participants will be assigned to use one of four placebo products: IVR (intravaginal ring) (approximately 20 participants), and vaginal insert, film or HEC universal placebo gel (approximately 10 participants each). Each woman will provide pre-product use vaginal swabs. Participants assigned to vaginal insert, film or gel will use products with and without timed intercourse with their male partner for a total of two doses of the product, will provide vaginal swabs post product use, and will be seen over 4 visits.
Participants assigned to IVR do not have to be sexually active with a male partner. IVR assigned participants will use a total of 3 IVRs, one at a time. IVR assigned participants will use the first IVR (IVR1) for approximately 24 - 36 hours (no exposure to semen during IVR1 use). IVR assigned participants will use a second IVR (IVR2) for approximately 7 - 10 days and a third IVR (IVR3) for approximately 28 - 32 days. During the use of IVR2 and IVR3, participants may engage in sexual intercourse, but it is not required. Women assigned to IVR use will be seen over 5 visits.
Once a woman completes the study cycle with one study product, she may elect to do another cycle using a different product after a wash-out period of at least 7 days, if she can comply with study product specific protocol requirements. She may elect to do up to four cycles, each with a different study product. For each cycle, V1 screening procedures will be repeated as indicated by symptoms and or participant history, as assessed by the investigator and as outlined in the study manual. If re-screening procedures are not indicated, the new cycle may start with Visit 2 (V2).
At Visit 1 (V1), volunteers will be consented and undergo procedures to confirm they are eligible to continue in the study. Participants will be counseled to refrain from vaginal activity, as applicable, for 48 hours prior to V2.
V2 should occur on days 3 - 10 of the menstrual cycle, or for participants who do not have regular menstrual cycles, when the participant is not having heavy menstrual bleeding. Once it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, baseline pre-product use vaginal swabs will be taken. Participants will be required to refrain from any vaginal activity until after Visit 3 (V3).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Volunteers must meet all of the following criteria prior to genital sampling at Visit 2:
- •Age 18 to 50 years, inclusive
- •General good health (by volunteer history and per investigator judgment) 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)
- •History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at V1
- •Willing to give voluntary consent and sign an informed consent form
- •Willing and able to comply with protocol requirements
- •Protected from pregnancy by:
- •hysterectomy
- •reliable methods of contraception other than male or female condoms, contraceptive IVR or male partner's vasectomy
- •abstinence (IVR group only)
- •or in a same sex relationship (IVR group only)
- •For gel, insert or film assigned participants: Willing to engage in intercourse with a male sexual partner without the use of male or female condoms as required in the protocol
- •For gel, insert or film assigned participants: In a mutually monogamous relationship with a male partner who:
- •Is at least 18 years old
- •Is not known to be HIV positive
- •Has no known risk for STIs
- •Has not undergone a vasectomy
- •Is not known to have azoospermia
- •Is willing and able to comply with protocol requirements regarding sexual activity/ abstinence
- •Can engage with the participant in vaginal intercourse without condoms, as specified in the protocol 8.2.
Exclusion Criteria
- •Volunteers must not meet any of the following criteria prior to genital sampling at Visit 2:
- •Currently pregnant
- •Currently breastfeeding or planning to breastfeed during the course of the study
- •History of sensitivity/allergy to any component of the vaginal products for either the volunteer or her sexual partner, as applicable
- •Use of vaginal douches, creams or gels, other than the study product, at any time during the study, beginning 7 days prior to V2
- •In the last six months, either the volunteer or her sexual partner (as applicable) diagnosed with or treated for any STI. Note: Women with a history of genital herpes who have been asymptomatic for at least six months may be considered for eligibility
- •Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis or HIV
- •Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
- •Known current drug or alcohol abuse which could impact study compliance
- •Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
- •Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her sexual partner (as applicable) which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
Outcomes
Primary Outcomes
Presence or absence of amelogenin
Time Frame: 1 - 7 days
Presence or absence of penetration of vaginally-derived biologic analytes or biofilms detected on returned IVRs
Time Frame: 1 - 7 days
Changes in dimensions, weight, biologic or chemical composition of IVR
Time Frame: 1 day, 1 week, 1 month
Assessments in dimensions, weight, biologic or chemical composition will be aggregated to inform changes in overall IVR characteristics
Presence or absence of spectroscopic pattern signatures or other analytical methods measures of excipient or placebo products or vaginal bacteria in vaginal swabs
Time Frame: 1 - 7 days
Presence or absence of DNA (deoxyribonucleic acid) sequences of SRY (Sex-determining region in the Y chromosome) and TSPY4 (testis-specific protein Y-encoded)
Time Frame: 1 - 7 days
Secondary Outcomes
- Changes on pelvic exam, as observed by the naked eye(baseline and at 1 day, 1 week and 1 month)
- Treatment-emergent adverse experiences among female participants per participant report: urogenital, product related, and/or serious(baseline and at 1 day, 1 week and 1 month)