HIV Clinical Trial
Official title:
A Phase IV, Open-Label, Single-Sequence Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Women
The purpose of this research sub-study is to learn about the levels of an antiretroviral
(ARV) medication called Raltegravir, and response to HIV virus in the genital tract of
HIV-positive women.
We would like to see how this study medication is tolerated, and how the body processes the
study medication in women who are HIV-positive. More specifically, we are interested in how
Isentress® might penetrate into the female cervicovaginal secretions thereby potentially
reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital
secretions may prevent female subjects from transmitting HIV to their sexual partners. This
information will help the research team know how a medication such as Isentress® might be
used to prevent the sexual transmission of HIV.
Purpose: This study aims to characterize the pharmacokinetics of raltegravir in
cervicovaginal fluids of HIV-infected women, and compare this to the blood plasma
pharmacokinetics being obtained in the main study, CID 0706.
Participants: Six HIV-positive women from the CID 0706 study Procedures: During the
pharmacokinetic visit to obtain blood plasma in the CID 0706 study, women will be asked to
self-collect cervicovaginal samples using a vaginal aspirator at the following timepoints:
pre-dose and 1, 2, 4, 6, 8, and 12 hours after raltegravir 400mg dose administration.
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Observational Model: Cohort, Time Perspective: Prospective
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