Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms

NCT02569697 | Completed Phase 1

• 1 other identifier: D15-135
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (5)

• Presence or absence of spectroscopic pattern signatures or other analytical methods measures of excipient or placebo products or vaginal bacteria in vaginal swabs

  1 - 7 days

• Presence or absence of penetration of vaginally-derived biologic analytes or biofilms detected on returned IVRs

  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)

  1 - 7 days

• Presence or absence of amelogenin

  1 - 7 days

• Changes in dimensions, weight, biologic or chemical composition of IVR

  Assessments in dimensions, weight, biologic or chemical composition will be aggregated to inform changes in overall IVR characteristics

  1 day, 1 week, 1 month

Secondary Outcomes (2)

• 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

• Changes on pelvic exam, as observed by the naked eye

  baseline and at 1 day, 1 week and 1 month

Study Arms (4)

HEC Placebo Gel

OTHER

The placebo gel will come in pre-filled individual applicators (4mL). Placebo gel is clear in color and contains HEC as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide.

Other: HEC Placebo gel

Placebo Vaginal Insert

OTHER

The placebo vaginal inserts will be supplied in white plastic bottles. The placebo inserts are white to off-white in color, uncoated and bullet-shaped. The inserts are composed of ingredients generally recognized as safe including isomalt, xylitol, polyvinylpyrrolidone K 30, hydroxypropyl methylcellulose, poloxamer, and sodium stearyl fumarate. The inserts are approximately ½ to 1 inch long and approximately ¼ to ½ inch thick, similar in size to vaginal tablets that are currently available.

Other: Placebo Vaginal Insert

Placebo Vaginal Film

OTHER

The placebo vaginal films will be individually wrapped. The placebo vaginal film is a thin, clear to translucent sheet with dimensions of 2 in x 2 in. The ingredients include hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC, E5), sodium carboxymethyl cellulose (NaCMC), and glycerin.

Other: Placebo Vaginal Film

Placebo Intravaginal ring (IVR)

OTHER

The placebo IVRs will be supplied in individual foil pouches. Each ring has a longer white to off-white segment and a shorter transparent/translucent segment, and ingredients include polyurethane, glycerin, water and modified starch.

Other: Placebo Intravaginal Ring

Interventions

HEC Placebo gel OTHER

HEC Placebo Gel

Placebo Intravaginal Ring OTHER

Placebo Intravaginal ring (IVR)

Placebo Vaginal Film OTHER

Placebo Vaginal Film

Placebo Vaginal Insert OTHER

Placebo Vaginal Insert

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• CONRAD: lead

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-09

Locations

US (1)