Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
|ClinicalTrials.gov Identifier: NCT01597180|
Recruitment Status : Withdrawn (Could not find subjects who met all the enrollment criteria so the study was stopped.)
First Posted : May 11, 2012
Last Update Posted : March 5, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
- Change in cervicovaginal fluide milieu
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|