NCT00561496|CompletedPhase 1
Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
Single Dose and 14-Day Once or Twice-Daily Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
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Single Dose and 14-Day Once or Twice-Daily Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
Sponsor study identifier
interventional
49
2 countries
3
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
April 2008
Actual (reported)This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase and a two-week once or twice-daily dosing phase for each of 49 volunteers. In the single-dose phase, each volunteer will apply the single dose in the clinic. Participants will be randomized to have cervicovaginal samples and biopsies collected at one of seven time-points \[0.5, 1, 2, 4, 6, 8, and 24 hour(s)\] after the single-dose. Blood samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose. In the two-week phase, the study supplies will be distributed and the participants will be randomized to apply each dose either once or twice-daily for two weeks. At the one week follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough value and cervicovaginal samples will be collected four hours after the morning dose. At the two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose. Participants will be randomized to have cervicovaginal samples and biopsies collected at either 4, 8 or 24 hours after the final morning dose. Up to 10 participants who have completed the first two phases of the study, will be asked to participate in a third phase to have cervicovaginal samples, biopsies and blood samples collected 12 hours after a single-dose.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 19, 2007
Actual (reported)November 21, 2007
Actual (reported)April 2008
Actual (reported)April 2008
Actual (reported)Concentration of tenofovir in local genital tract compartments (intraluminal, mononuclear cells and vaginal tissue levels). Concentration (Cmax) and time of maximum concentration (Tmax) of tenofovir in the systemic compartment.
Single dose; two weeks (after once or twice-daily vaginal administration)
Tenofovir gel intravaginal twice daily for 14 days
Tenofovir gel intravaginal once daily for 14 days
Intravaginal (4grams)single dose followed by fourteen days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Advances in Health, Inc
Houston, Texas, 77030, United States
Profamilia
Santo Domingo, Dominican Republic
Schwartz JL, Rountree W, Kashuba AD, Brache V, Creinin MD, Poindexter A, Kearney BP. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel. PLoS One. 2011;6(10):e25974. doi: 10.1371/journal.pone.0025974. Epub 2011 Oct 19.
Jill Schwartz, MD
CONRAD
49 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2007
First Posted
November 21, 2007
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Contact the study team to confirm eligibility.
Primary Completion
April 2008
Actual (reported)Study Completion
April 2008
Actual (reported)Last Updated
May 28, 2008
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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