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Sponsors and Collaborators: |
University of Rochester Merck |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00745368 |
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
Condition | Intervention |
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HIV Infections |
Drug: Raltegravir |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Comparing Raltegravir Genital Tract Distribution in HIV-Infected Men and Women |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA
Exclusion Criteria:
Contact: Robert DiCenzo, Pharm.D. | 585-451-2543 | robert_dicenzo@urmc.rochester.edu |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Robert DiCenzo, Pharm.D. 585-451-2543 robert_dicenzo@urmc.rochester.edu | |
Principal Investigator: Robert DiCenzo, Pharm.D. | |
Sub-Investigator: Amneris Luque, MD |
Responsible Party: | University of Rochester ( Robert DiCenzo, Pharm.D. ) |
Study ID Numbers: | 33113 |
Study First Received: | September 1, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00745368 |
Health Authority: | United States: Institutional Review Board |
HIV Raltegravir pharmacokinetics Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |