Concentrations of Raltegravir in the Semen of HIV-Infected Men

Study to Determine the Concentrations of Raltegravir in Semen, the Seminal to Plasma Ratio of Raltegravir and the Variability in Seminal to Plasma Ratios Over the Raltegravir Dosing Period.

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Seminal plasma pharmacokinetics

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5B 1L6
      • Canadian Immunodeficiency Research Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

12 HIV-positive males

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Raltegravir treated men; Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seminal Concentrations of Raltegravir.	Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semen to Plasma Raltegravir Concentrations	Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.	6 months
Seminal Distribution of Raltegravir	Determine the area under the concentration time curve of raltegravir in semen.	6 months
Semen to Plasma Distribution of Raltegravir	Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.	6 months

Collaborators and Investigators

• Sponsor: Canadian Immunodeficiency Research Collaborative
• Investigators: Principal Investigator: Mona Loutfy, MD, MPH, Maple Leaf Medical Research; Principal Investigator: Tony Antoniou, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 12, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: MISP35369