Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02569697|
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: HEC Placebo gel Other: Placebo Intravaginal Ring Other: Placebo Vaginal Film Other: Placebo Vaginal Insert||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
HEC Placebo Gel
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
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
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)
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
- 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 penetration of vaginally-derived biologic analytes or biofilms detected on returned IVRs [ 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 ]
- Presence or absence of amelogenin [ 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
- Treatment-emergent adverse experiences among female participants per participant report: urogenital, product related, and/or serious [ Time Frame: baseline and at 1 day, 1 week and 1 month ]
- Changes on pelvic exam, as observed by the naked eye [ Time Frame: baseline and at 1 day, 1 week and 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569697
|United States, Virginia|
|Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23507|