Concentrations of Raltegravir in the Semen of HIV-Infected Men
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ClinicalTrials.gov Identifier: NCT01045265 |
Recruitment Status
:
Completed
First Posted
: January 11, 2010
Results First Posted
: August 13, 2014
Last Update Posted
: August 13, 2014
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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.
Condition or disease | Intervention/treatment |
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HIV | Other: Seminal plasma pharmacokinetics |
Study Type : | Observational |
Actual Enrollment : | 16 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 Start Date : | December 2009 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | July 2012 |

Group/Cohort | Intervention/treatment |
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Raltegravir treated men
Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy
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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.
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- Seminal Concentrations of Raltegravir. [ Time Frame: 6 months ]Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.
- Semen to Plasma Raltegravir Concentrations [ Time Frame: 6 months ]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 ]Determine the area under the concentration time curve of raltegravir in semen.
- Semen to Plasma Distribution of Raltegravir [ Time Frame: 6 months ]Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045265
Canada, Ontario | |
The Ottawa Hospital | |
Ottawa, Ontario, Canada | |
Canadian Immunodeficiency Research Collaborative | |
Toronto, Ontario, Canada, M5B 1L6 |
Principal Investigator: | Mona Loutfy, MD, MPH | Maple Leaf Medical Research | |
Principal Investigator: | Tony Antoniou | St. Michael's Hospital, Toronto |
Responsible Party: | Canadian Immunodeficiency Research Collaborative |
ClinicalTrials.gov Identifier: | NCT01045265 History of Changes |
Other Study ID Numbers: |
MISP35369 |
First Posted: | January 11, 2010 Key Record Dates |
Results First Posted: | August 13, 2014 |
Last Update Posted: | August 13, 2014 |
Last Verified: | August 2014 |
Additional relevant MeSH terms:
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |