Levels of Raltegravir in the Female Genital Tissue
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the
female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug
levels to prevent viral integration of HIV-1. The study will also assess whether drug levels
change in the tissue across the different phases of the menstrual cycle.
- Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular
concentrations that should be sufficient to suppress HIV-1 replication throughout the
menstrual cycle.
- Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher
compared to extracellular concentrations in the plasma and PMBCs (peripheral blood
mononuclear cells).
- Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during
the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein,
which are present in higher numbers during periods of high progesterone.