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A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women

NCT00774683 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2011-10-25

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Raltegravir (Isentress®)

400 mg p.o. BID x 7 days

Sponsors & Collaborators

Principal Investigators

  • Kristine B Patterson, MD · University of North Carolina, Chapel Hill

  • Angela DM Kashuba, PharmD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00774683 on ClinicalTrials.gov