A Phase I Investigation of Single-Dose Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions
Sponsor study identifier
interventional
49
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal tissues. This will be accomplished by determining the pharmacokinetic disposition and dose proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal tissue.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click 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.
August 17, 2010
Actual (reported)April 6, 2011
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2013
Actual (reported)August 2013
Actual (reported)Dose Proportionality
To determine if antiretroviral mucosal fluid and tissue concentrations change proportionally with a change in antiretroviral dose.
48 hours
Subjects will receive a single dose of tenofovir 150 mg and maraviroc 150 mg.
Subjects will receive a single dose of tenofovir 300 mg and maraviroc 300 mg.
Subjects will receive a single dose of tenofovir 600 mg and maraviroc 600 mg.
Blood plasma, Rectal, Cervical, and Vaginal Tissues and Secretions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UNC Hospitals CTRC
Chapel Hill, North Carolina, 27514, United States
Tompkins LAR, Khoei A, Kapeljushnik O, Dumond J, Kashuba ADM, Tropsha A, Hubal R, Cottrell ML. HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies. Clin Pharmacol Ther. 2025 Dec;118(6):1340-1349. doi: 10.1002/cpt.3699. Epub 2025 May 12.
Angela DM Kashuba, PharmD
University of North Carolina, Chapel Hill
49 participants (actual enrollment reported by the registry).
First Submitted
August 17, 2010
First Posted
April 6, 2011
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Subjects will receive a single dose of emtricitabine 100 mg and raltegravir 200 mg.
Subjects will receive a single dose of emtricitabine 200 mg and raltegravir 400 mg.
Subjects will receive a single dose of emtricitabine 400 mg and raltegravir 800 mg.
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
September 17, 2013
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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