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

January 8, 2010
August 12, 2014
December 2009
September 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01045265 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

12 HIV-positive males

HIV
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.
Raltegravir treated men
Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy
Intervention: Other: Seminal plasma pharmacokinetics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2012
September 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01045265
MISP35369
No
Canadian Immunodeficiency Research Collaborative
Canadian Immunodeficiency Research Collaborative
Not Provided
Principal Investigator: Mona Loutfy, MD, MPH Maple Leaf Medical Research
Principal Investigator: Tony Antoniou St. Michael's Hospital, Toronto
Canadian Immunodeficiency Research Collaborative
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP