Concentrations of Raltegravir in the Semen of HIV-Infected Men

HIV Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045265
• Other study ID #: MISP35369
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: August 12, 2014
• Start date: December 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: Canadian Immunodeficiency Research Collaborative
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Canadian Immunodeficiency Research Collaborative	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Immunodeficiency Research Collaborative

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Seminal Distribution of Raltegravir	Determine the area under the concentration time curve of raltegravir in semen.	6 months	No
Secondary	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	No