Clinical trial NCT01009034: Concentrations of Maraviroc in the Semen of HIV-Infected Men
Official title: Study to Determine the Concentrations of Maraviroc in Semen, the Seminal to Plasma Ratio of Maraviroc and the Variability in Seminal to Plasma Ratios Over the Maraviroc Dosing Period.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maraviroc Concentrations in Semen
Lead sponsor: Canadian Immunodeficiency Research Collaborative
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 14
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 maraviroc in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extent of maraviroc penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of maraviroc in semen, and to determine the variability in the penetration of maraviroc into the seminal compartment over the maraviroc dosing period.

Detailed description: The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc 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 maraviroc 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/uL
* AST, 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: Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.
timeFrame: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.
Secondary outcomes:
measure: Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval
timeFrame: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample
measure: Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.
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:
References: