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Concentrations of Raltegravir in the Semen of HIV-Infected Men

NCT01045265 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2014-08-13

Study results available
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Summary

The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.

Conditions

Interventions

OTHER

Seminal plasma pharmacokinetics

Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.

Sponsors & Collaborators

  • Canadian Immunodeficiency Research Collaborative

    lead OTHER

Principal Investigators

  • Mona Loutfy, MD, MPH · Maple Leaf Medical Research

  • Tony Antoniou · Unity Health Toronto

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-09-30
Completion
2012-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01045265 on ClinicalTrials.gov