Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT01009034)
8 september 2014 bijgewerkt door: Canadian Immunodeficiency Research Collaborative
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.
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
14
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5B1L6
- Canadian Immunodeficiency Research Collaborative
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
12 HIV-positive males
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.
Tijdsspanne: 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.
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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.
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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.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval
Tijdsspanne: 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
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For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.
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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
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Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.
Tijdsspanne: 6 months
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6 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2009
Primaire voltooiing (Werkelijk)
1 december 2011
Studie voltooiing (Werkelijk)
1 december 2012
Studieregistratiedata
Eerst ingediend
5 november 2009
Eerst ingediend dat voldeed aan de QC-criteria
5 november 2009
Eerst geplaatst (Schatting)
6 november 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
9 september 2014
Laatste update ingediend die voldeed aan QC-criteria
8 september 2014
Laatst geverifieerd
1 september 2014
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- WS 353380
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