Trial Outcomes & Findings for Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid (NCT NCT00729924)

NCT ID: NCT00729924

Last Updated: 2015-03-03

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: Day 7
• Results posted on: 2015-03-03

Participant Flow

Participant milestones

Measure	Raltegravir 400mg Orally Every 12 Hours for 7 Days. Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Baseline characteristics by cohort

Measure	Raltegravir: 400mg Orally Every 12 Hours for 7 Days n=40 Participants Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
Age, Continuous	34.5 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Cerebrospinal Fluid Protein	33 mg/dL n=5 Participants
Weight	74.6 kilograms n=5 Participants
Body Mass Index	24.0 kilgrams/(meter squared) n=5 Participants
ABCB1 Genotype C/C Genotype	20 participants n=5 Participants
ABCB1 Genotype T/T Genotype	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C n=20 Participants Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.	Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T n=20 Participants Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.	0.0066 1/h Interval 0.005 to 0.0081	0.0070 1/h Interval 0.006 to 0.0095

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C n=20 Participants Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.	Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T n=20 Participants Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.	0.028 ratio Interval 0.014 to 0.057	0.021 ratio Interval 0.016 to 0.045

Adverse Events

Raltegravir: 400mg Orally Every 12 Hours for 7 Days

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Raltegravir: 400mg Orally Every 12 Hours for 7 Days n=40 participants at risk Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
Nervous system disorders post-lumbar puncture headache	2.5% 1/40 • Number of events 1

Additional Information

David W. Haas, MD

Vanderbilt University

Phone: 615-936-8594

Email: david.w.haas@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place