NCT02280109|CompletedEarly Phase 1
Comparison of Tenofovir Vaginal Gel and Film Formulations
FAME-05
Comparison of the Pharmacokinetics and Pharmacodynamics of Single Dose Tenofovir Vaginal Gel and Film Formulation
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FAME-05
Comparison of the Pharmacokinetics and Pharmacodynamics of Single Dose Tenofovir Vaginal Gel and Film Formulation
Sponsor study identifier
Secondary identifiers
NIH
interventional
10
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
Not reported
Date not reportedThis is an open label comparative study of tenofovir gel and film in 10 healthy sexually active women without active female genital tract disorders. The women will receive a single dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and tenofovir film (1.3%;40 mg) - in a crossover study design to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid (primary objective).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2014
Actual (reported)October 31, 2014
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2015
Actual (reported)Plasma tenofovir concentration-time curve (AUC0-72) for each product (film and gel) 0 thru 72 hours after dosing
Concentration-time plot of plasma tenofovir
72 hours
PBMC tenofovir diphosphate concentration-time curve (AUC0-72) for each product (film and gel) 0 thru 72 hours after dosing
Concentration-time plot of PBMC tenofovir diphosphate thru 72 hours after dosing
72 hours
Cervical tissue tenofovir maximum concentration (Cmax) at 5 hours
5 hours
Cervical tissue tenofovir maximum concentration (Cmax) at 72 hours
72 hours
Cumulative HIV p24 protein concentration from 0 to 15 days post ex-vivo infection of explant cervical tissue collected at 5 hours after dosing with tenofovir gel or film
15 days
Cumulative HIV p24 protein concentration from 0 to 15 days post ex-vivo infection of explant cervical tissue collected at 72 hours after dosing with tenofovir gel or film
15 days
Women will receive a single dose of tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid.
Women will receive a single dose of tenofovir film (1.3%;40 mg) to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid.
single dose of 1% tenofovir gel (equivalent to 40 mg in 4ml's of gel)
single dose of 1.3% tenofovir film (equivalent to 40 mg)
Johns Hopkins University School of Medicine Division of Clinical Pharmacology
Baltimore, Maryland, 21287-5554, United States
Craig W Hendrix, MD
Johns Hopkins University
10 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2014
First Posted
October 31, 2014
Study Start
November 2014
Date type not reportedAn Open Label Study of IgG Fc Glycan Composition in Human Immunity
Cervical tissue tenofovir diphosphate maximum concentration (Cmax) at 5 hours
5 hours
Cervical tissue tenofovir diphosphate maximum concentration (Cmax) at 72 hours
72 hours
Cervicovaginal fluid tenofovir maximum concentration (Cmax) at 5 hours
5 hours
Cervicovaginal fluid tenofovir maximum concentration (Cmax) at 72 hours
72 hours
Rectal fluid tenofovir maximum concentration (Cmax) at 5 hours
5 hours
Rectal fluid tenofovir maximum concentration (Cmax) at 72 hours
72 hours
All adverse clinical and laboratory events
Categorize adverse events by treatment formulation to compare the safety of single dose tenofovir gel and film formulations
one year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Last Updated
January 28, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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