Clinical trial NCT01045265: Concentrations of Raltegravir in the Semen of HIV-Infected Men
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Canadian Immunodeficiency Research Collaborative
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 12 HIV-positive males

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.

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

Primary outcomes:
measure: Seminal Concentrations of Raltegravir.
timeFrame: 6 months
Secondary outcomes:
measure: Semen to Plasma Raltegravir Concentrations
timeFrame: 6 months
measure: Seminal Distribution of Raltegravir
timeFrame: 6 months
measure: Semen to Plasma Distribution of Raltegravir
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Canadian Immunodeficiency Research Collaborative
state: Ontario
Study officials:
affiliation: Maple Leaf Medical Research
name: Mona Loutfy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Tony Antoniou
role: PRINCIPAL_INVESTIGATOR
References: