Status:
COMPLETED
A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women
Lead Sponsor:
Kristine Patterson, MD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
AIDS
Eligibility:
FEMALE
18-49 years
Brief Summary
The purpose of this research sub-study is to learn about the levels of an antiretroviral (ARV) medication called Raltegravir, and response to HIV virus in the genital tract of HIV-positive women. We ...
Detailed Description
Purpose: This study aims to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids of HIV-infected women, and compare this to the blood plasma pharmacokinetics being obtained in the...
Eligibility Criteria
Inclusion
- HIV-1 infection documented by HIV serology or detectable viral load
- Self-described as African-American
- Less than 7 days cumulative of prior HIV therapy
- Plasma HIV RNA PCR equal to or greater than 1000 copies/mL within 90 days prior to study entry
- Able to provide informed consent
- In the opinion of the investigator, able to comply with study medication and procedures
- ALT (SGPT) \< or equal to 3.0 x ULN within 45 days prior to study entry
- GRF \> 60 as calculated by MDRD within 45 days prior to study entry
- All women of reproductive potential (who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum or urine β-HCG pregnancy test performed within 48 hours before entry.
- All study volunteers must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, 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; or hormonal-based contraception), simultaneously while receiving the protocol-specified medication(s) and for 6 weeks after stopping the medication(s).
Exclusion
- Pregnancy
- Breastfeeding
- Prior receipt of Raltegravir
- 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, HSV-2 (active lesions), or trichomonas at entry or week 2 of the main study, CID 0706
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00774683
Start Date
August 1 2008
End Date
September 1 2009
Last Update
October 25 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514