Concentrations of Raltegravir in the Semen of HIV-Infected Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT01045265
First received: January 8, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
HIV
Other: Seminal plasma pharmacokinetics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Primary Outcome Measures:
  • Seminal Concentrations of Raltegravir. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.


Secondary Outcome Measures:
  • Semen to Plasma Raltegravir Concentrations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.

  • Seminal Distribution of Raltegravir [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine the area under the concentration time curve of raltegravir in semen.

  • Semen to Plasma Distribution of Raltegravir [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.


Enrollment: 16
Study Start Date: December 2009
Study Completion Date: July 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

12 HIV-positive males

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045265

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, Canada, M5B 1L6
Sponsors and Collaborators
Canadian Immunodeficiency Research Collaborative
Investigators
Principal Investigator: Mona Loutfy, MD, MPH Maple Leaf Medical Research
Principal Investigator: Tony Antoniou St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT01045265     History of Changes
Other Study ID Numbers: MISP35369
Study First Received: January 8, 2010
Results First Received: June 16, 2014
Last Updated: August 12, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014