A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women
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|ClinicalTrials.gov Identifier: NCT00774683|
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 25, 2011
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 would like to see how this study medication is tolerated, and how the body processes the study medication in women who are HIV-positive. More specifically, we are interested in how Isentress® might penetrate into the female cervicovaginal secretions thereby potentially reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital secretions may prevent female subjects from transmitting HIV to their sexual partners. This information will help the research team know how a medication such as Isentress® might be used to prevent the sexual transmission of HIV.
|Condition or disease||Intervention/treatment|
|HIV AIDS||Drug: Raltegravir (Isentress®)|
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 main study, CID 0706.
Participants: Six HIV-positive women from the CID 0706 study Procedures: During the pharmacokinetic visit to obtain blood plasma in the CID 0706 study, women will be asked to self-collect cervicovaginal samples using a vaginal aspirator at the following timepoints: pre-dose and 1, 2, 4, 6, 8, and 12 hours after raltegravir 400mg dose administration.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||A Phase IV, Open-Label, Single-Sequence Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Women|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Sub-study Group A
Six HIV-positive African American women from the main study, CID 0706
Drug: Raltegravir (Isentress®)
400 mg p.o. BID x 7 days
- 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 main study, CID 0706. [ Time Frame: Single Time Point Measurement at 4 Weeks after ART Initiation ]
Biospecimen Retention: Samples With DNA
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): NCT00774683
|United States, North Carolina|
|The University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Kristine B Patterson, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Angela DM Kashuba, PharmD||University of North Carolina, Chapel Hill|