This study is being conducted to determine if the uptake of anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues.
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of MSM acquire HIV after exposure to the rectal mucosa through unprotected receptive anal intercourse. Post-exposure-prophylaxis (PEP) is an intervention that is used to prevent HIV infection soon (72 hours) after a potential exposure. HIV-negative people with a possible exposure to HIV are instructed to take 28 days of a combination anti-HIV medication regimen, Truvada® + Raltegravir. This study is being conducted to determine if the uptake of other anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues. These other medications might be considered for PEP regimens in the future.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
35
Men will be instructed to take Single dose of Genvoya® and a single 800 mg dose of Darunavir® per oral
Emory University
Atlanta, Georgia, United States
Median Genvoya plasma concentration
Approximately 24 mL of blood will be drawn to obtain Genvoya plasma concentration (median + range; ng/mL)
Time frame: 2 to up to 96 hours after time of dose
Median Darunavir plasma concentration
Approximately 24 mL of blood will be drawn to obtain Darunavir plasma concentration (median + range; ng/mL)
Time frame: 2 to up to 96 hours after time of dose
Median Genvoya rectal tissue distribution
Rectal biopsy via rigid sigmoidoscopy will be performed to obtain Genvoya rectal tissue distribution (median + range; ng/mg of tissue).
Time frame: 2 to up to 96 hours after time of dose
Median Darunavir rectal tissue distribution
Rectal biopsy via rigid sigmoidoscopy will be performed to obtain Darunavir rectal tissue distribution (median + range; ng/mg of tissue).
Time frame: 2 to up to 96 hours after time of dose
Median Genvoya rectal secretion concentration
Rectal swabs for Genvoya rectal secretion concentration (median + range; ng/swab)
Time frame: 2 to up to 96 hours after time of dose
Median Darunavir rectal secretion concentration
Rectal swabs for Darunavir rectal secretion concentration (median + range; ng/swab)
Time frame: 2 to up to 96 hours after time of dose
Median Genvoya urethral secretion concentration
Urethral swab for Genvoya urethral secretion concentration (median + range; ng/swab)
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Time frame: 2 to up to 96 hours after time of dose
Median Darunavir urethral secretion concentration
Urethral swab for Darunavir urethral secretion concentration (median + range; ng/swab)
Time frame: 2 to up to 96 hours after time of dose