Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid
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|ClinicalTrials.gov Identifier: NCT00729924|
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : March 3, 2015
Last Update Posted : March 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Raltegravir||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Open label oral raltegravir
Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
400mg orally every 12 hours for 7 days
Other Name: MK-0518
- Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve. [ Time Frame: Day 7 ]The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).
- Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint. [ Time Frame: Day 7 ]This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).
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): NCT00729924
|United States, Tennessee|
|Vanderbilt Therapeutics Clinical Research Site|
|Nashville, Tennessee, United States, 37204|
|Principal Investigator:||David W Haas, MD||Vanderbilt University Medical Center|