Evaluating the Pharmacokinetics of 400 mg Oral Dose of Raltegravir in HIV-Infected Pre-Menopausal Women

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00961272

Run by

Kristine Patterson, MD

People needed

6

Starts

2009-07-01

Expected to finish

2010-02-01

Last updated by the study team

2014-02-28

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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