Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000171415
Ethics application status
Approved
Date submitted
9/03/2007
Date registered
15/03/2007
Date last updated
27/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Activity and Safety of SCH 532706 in HIV-1 Infected Subjects
Scientific title
To evaluate the virologic activity of SCH 532706 coadministered with ritonavir in CCR5-tropic HIV-infected individuals.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CCR5-tropic HIV-Infected Individuals 1686 0
Condition category
Condition code
Infection 1781 1781 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1644 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2488 0
Virologic activity; subjects will have HIV-1 viral Ribonucleic acid (RNA) values measured
Timepoint [1] 2488 0
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.
Secondary outcome [1] 4293 0
Pharmacokinetic profile; plasma samples for analysis will be collected.
Timepoint [1] 4293 0
* 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.

Eligibility
Key inclusion criteria
* Documented HIV infection* Must have a BMI of between 19 to 35 inclusive* Must have CCR5 tropism only.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1931 0
Commercial sector/Industry
Name [1] 1931 0
Schering-Plough
Country [1] 1931 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
2000 Galloping Hill Rd, NJ 7033
Country
United States of America
Secondary sponsor category [1] 1743 0
None
Name [1] 1743 0
Nil
Address [1] 1743 0
Country [1] 1743 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of this study is to assess the virologic activity, safety, tolerability and pharmacodynmaic profile of SCH 532706 when codminstered with a dose of Ritonavir that could be observed during the treatment of patients with HIV.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27578 0
Address 27578 0
Country 27578 0
Phone 27578 0
Fax 27578 0
Email 27578 0
Contact person for public queries
Name 10833 0
Dr Sarah Pett
Address 10833 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Sydney NSW 2000
Country 10833 0
Australia
Phone 10833 0
+61 2 93850900
Fax 10833 0
Email 10833 0
[email protected]
Contact person for scientific queries
Name 1761 0
Dr Sarah Pett
Address 1761 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Sydney NSW 2000
Country 1761 0
Australia
Phone 1761 0
+61 2 93850900
Fax 1761 0
Email 1761 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.