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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12607000171415 |
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Date of registration:
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15/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Activity and Safety of SCH 532706 in HIV-1 Infected Subjects
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Scientific title:
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To evaluate the virologic activity of SCH 532706 coadministered with ritonavir in CCR5-tropic HIV-infected individuals. |
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Date of first enrolment:
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06/03/2007 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12607000171415.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Pharmacokinetics;
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Sarah Pett
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Address:
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National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Sydney NSW 2000
Australia |
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Telephone:
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+61 2 93850900 |
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Email:
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spett@nchecr.unsw.edu.au |
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Affiliation:
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Name:
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Dr Sarah Pett
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Address:
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National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Sydney NSW 2000
Australia |
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Telephone:
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+61 2 93850900 |
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Email:
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spett@nchecr.unsw.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: * Documented HIV infection* Must have a BMI of between 19 to 35 inclusive* Must have CCR5 tropism only.
Exclusion criteria: * Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding* Subject's with history of a seizure disorder* Subject with a mental instability.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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CCR5-tropic HIV-Infected Individuals;
CCR5-tropic HIV-Infected Individuals
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Infection - Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention(s)
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This is a single-site, fixed sequence, open label, evaluation of SCH 532706 plus ritonavir. Each patient will receive 20 doses of SCH 532706 and 10 doses of ritonavir over 10 days.
SCH 532706 60mg administered twice daily as an oral solution (at 2mg/mL)
Ritonavir 100mg will be administered once daily as a single capsule.
Each patient will be given SCH 532706 morning (AM) and night and Ritonavir each morning (AM) for 10 days.
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Primary Outcome(s)
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Virologic activity; subjects will have HIV-1 viral Ribonucleic acid (RNA) values measured[Measured on study day -1 (one day prior to the first dose) and days 1, 3, 5, 7, 10, 15, 20 and 25 after the first dose.]
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Secondary Outcome(s)
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Pharmacokinetic profile; plasma samples for analysis will be collected.[* Day 1 and Day 10, predose that is 0 hours, and 0.5, 1, 1.5, 2, 4, 6, and 12 hours post AM dose.
* Days 3, 5, and 7, samples will be collected before the AM dose.]
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Source(s) of Monetary Support
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Schering-Plough
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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