Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT01009034)
8 september 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
14
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital
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Toronto, Ontario, Kanada, M5B1L6
- Canadian Immunodeficiency Research Collaborative
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
12 HIV-positive males
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval
Tidsram: 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
|
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.
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2009
Primärt slutförande (Faktisk)
1 december 2011
Avslutad studie (Faktisk)
1 december 2012
Studieregistreringsdatum
Först inskickad
5 november 2009
Först inskickad som uppfyllde QC-kriterierna
5 november 2009
Första postat (Uppskatta)
6 november 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- WS 353380
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .