Concentrations of Raltegravir in the Semen of HIV-Infected Men

NCT01045265 | Completed Results

• 1 other identifier: MISP35369
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Seminal Concentrations of Raltegravir.

  Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.

  6 months

Secondary Outcomes (3)

• Semen to Plasma Raltegravir Concentrations

  6 months

• Seminal Distribution of Raltegravir

  6 months

• Semen to Plasma Distribution of Raltegravir

  6 months

Study Arms (1)

Raltegravir treated men

Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy

Other: Seminal plasma pharmacokinetics

Interventions

Seminal plasma pharmacokinetics OTHER

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

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 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

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/ 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

Sponsors & Collaborators

• Canadian Immunodeficiency Research Collaborative: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Canadian Immunodeficiency Research Collaborative

Toronto, Ontario, M5B 1L6, Canada

Location

Results Point of Contact

• Title: Tony Antoniou
• Organization: Maple Leaf Research

tantoniou@smh.toronto.on.ca

4164657936

Study Officials

• Mona Loutfy, MD, MPH

  Maple Leaf Medical Research

  PRINCIPAL INVESTIGATOR

• Tony Antoniou

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

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: January 8, 2010
• First Posted: January 11, 2010
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: August 13, 2014
• Results First Posted: August 13, 2014

Record last verified: 2014-08

Locations

CA (2)