Status:
COMPLETED
Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women
Lead Sponsor:
Kristine Patterson, MD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
FEMALE
18-49 years
Brief Summary
The purpose of this study is to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids as compared to blood plasma of HIV-infected pre-menopausal women.
Detailed Description
Participants: Six HIV-positive pre-menopausal women already undergoing therapy with raltegravir. Procedures (methods): This study will be conducted at a single site: the University of North Carolina ...
Eligibility Criteria
Inclusion
- HIV-1 infection documented by HIV serology or detectable viral load
- Able to provide informed consent
- In the opinion of the investigator, able to comply with their treatment regimen and study procedures
- Currently receiving raltegravir as treatment for HIV infection. Subjects must have been on raltegravir for at least 3 weeks prior to the inpatient pharmacokinetic sampling stay.
- All women of reproductive potential (who have not reached menopause or undergone bilateral oophorectomy, or tubal ligation) must have a negative serum β-HCG pregnancy test performed at screening.
- Subjects must test negative for sexually transmitted infections (gonorrhea, chlamydia, trichomonas, bacterial vaginosis, or syphilis) at screening
- All study volunteers must agree not to participate in a conception process (e.g., active attempt to become pregnant).
- Subjects must be willing to abstain from intercourse, and vaginal instrumentation, including douching, within the 48 hours prior to all study visits.
- If participating in sexual activity that could lead to pregnancy between study visits, the female study volunteer/male partner must use at least one reliable method of contraception (e.g., condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD)
Exclusion
- Pregnancy
- Breastfeeding
- Any condition which in the opinion of the investigator is likely to interfere with follow-up or ability to take the study medication appropriately
- A positive test for bacterial vaginosis, syphilis, gonorrhea, chlamydia, or trichomonas
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00961272
Start Date
July 1 2009
End Date
February 1 2010
Last Update
February 28 2014
Active Locations (1)
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1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7215