Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597180
|United States, North Carolina|
|UNC Infectious Disease Clinic|
|Chapel Hill, North Carolina, United States, 27516|
|Principal Investigator:||Gretchen S Stuart, MD||University of North Carolina, Chapel Hill|