Pharmacokinetics, pharmacodynamics, and genital tract viral shedding in HIV+ women using combined oral contraceptives and raltegravir

Sponsor

Merck Sharp and Dohme

Principal Investigator

Dr. Gretchen Stuart, Obstetrics and Gynecology

Project Run Dates

5/30/2012 to 5/29/2015

Total Award Amount

$97,165.13

 

Summary

The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators  plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses. The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.
   

Associated Publications and other materials

Study Record Detail via Clinical Trials.gov

Associated Award Numbers: A12-1257-002, A12-1257-003