Concentrations of Maraviroc in the Semen of HIV-Infected Men

NCT01009034 | Completed Results

• 1 other identifier: WS 353380
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Maraviroc Concentrations in Semen

Outcome Measures

Primary Outcomes (1)

• Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.

  We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Specifi- cally, 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. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.

  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 (2)

• Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval

  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

• Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.

  6 months

Study Arms (1)

12 male HIV-positive patients

Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.

Other: Measuring semen samples

Interventions

Measuring semen samples OTHER

Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.

12 male HIV-positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

12 HIV-positive males

You may qualify if:

• HIV infected male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Immunodeficiency Research Collaborative: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Canadian Immunodeficiency Research Collaborative

Toronto, Ontario, M5B1L6, Canada

Location

Results Point of Contact

• Title: Tony Antoniou
• Organization: Maple Leaf Research

tantoniou@smh.toronto.on.ca

4164657936

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 9, 2014
• Results First Posted: September 9, 2014

Record last verified: 2014-09

Locations

CA (2)