Concentrations of Raltegravir in the Semen of HIV-Infected Men

NCT ID: NCT01045265

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-07-31

Brief 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.

Detailed Description

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load < 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Raltegravir treated men

Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy

Seminal plasma pharmacokinetics

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HIV infected male
• 18 years old or older
• on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening
• viral load < 50 copies/mL at least one month prior to enrolling
• able to read, understand and sign a written informed consent prior to initiation of the study
• medically stable at the time of the study, with no evidence of acute illness

Exclusion Criteria

• having difficulty adhering to current antiretroviral therapy
• patient is expected to have difficulties adhering with study protocol
• patients with malignancy, or acute renal or liver disease
• patient with active AIDS-defining illness
• patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent
• patient with any of the following abnormalities at the time of screening:
• hemoglobin < 85 g/L
• absolute neutrophil count < 1000 cells/uL
• platelet count < 50,000 cells/ microleter (uL)
• aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin > 3 times the upper limit of normal
• serum creatinine > 1.5 times upper limit of normal
• patient receiving concomitant therapy with rifampin or St. John's wort

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Immunodeficiency Research Collaborative

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Loutfy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Maple Leaf Medical Research

Tony Antoniou

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Canadian Immunodeficiency Research Collaborative

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MISP35369

Identifier Type: -

Identifier Source: org_study_id