HIV Infections Clinical Trial
Official title:
Single Dose and 14-Day Once or Twice-Daily Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
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.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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