Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
To compare drug concentrations in vaginal fluid, genital tissue, and blood
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Current sexual partner known by participant to be HIV seropositive.
Individuals who, by history, engage in condom-less intercourse with HIV-infected partners, or partners that have unknown HIV serostatus, or women who exchange sex for money, shelter, or gifts.
Active sexually transmitted infection or documented treatment of sexually transmitted infections including, but not limited to: chlamydia, gonorrhea, syphilis, trichomonas, cervicitis or PID within 6 months prior to enrollment.
Known history of genital HSV (diagnosed by either clinical or laboratory test).
Symptomatic vaginal candidiasis or bacterial vaginosis.
Undiagnosed irregular uterine bleeding
Pathology of the female genital tract, which in the judgment of the investigator might increase the risk of the study to the research participant.
Individuals who are status post hysterectomy.
History of any cervicovaginal procedure (i.e. colposcopy with cervical biopsy) within the past 2 months. Individuals who have a history of cone biopsy or extensive loop electrosurgical excision procedure (LEEP), which in the judgment of the investigator may affect permeability assessment.
Any known primary or secondary uro-genital malformations, which in the assessment of the investigator may interfere with the intended urine collection for PK studies.
Use of vaginally administered medications within 4 week of enrollment
Any active urinary tract infection
By history, subjects with irregular menstrual cycles.
At screening:
Estimated creatinine clearance < 60 ml/min based on established nomograms
Recent history (past 6 months) of injection drug use or, a level of alcohol use that, in the judgement of the Investigator of Record, may interfere with the conduct of this study.
Unwillingness to refrain from aspirin and NSAIDs product use for one week prior to and one week post study procedures.
Use of warfarin or heparin.
Use of systemic immunomodulatory medications within 4 weeks of enrollment.
Use of product containing nonoxynol-9 within 4 weeks of enrollment.
Use of any investigational products within 4 weeks of enrollment.
Any other medical conditions deemed not safe for participation by the investigator.
Any individual that is actively breast feeding.
Post-menopausal defined as 12 months of amenorrhea.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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