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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 083364
ACTR Number: ACTRN12609000014257
Trial Status: Registered
Date Submitted: 14/11/2008
Date Registered: 8/01/2009

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Public title: Cardiovascular function with switching from Kivexa to Truvada (or from Abacavir to Tenofovir).
ANZCTR registration title: Cardiovascular function with switching from Kivexa to Truvada (or from Abacavir to Tenofovir) in people with Human Immunodeficiency Virus (HIV).
Secondary ID: 
UTN:
Trial acronym: SKiT

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Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 
Cardiovascular function 
Condition category: Condition code:
Infection Acquired immune deficiency syndrome (AIDS / HIV) 

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Description of intervention(s) / exposure: using applanation tonometry to evaluate cardiovascular function in adults with HIV infection switching from ABC-3TC (Kivexa) to TDF-FTC (Truvada) or from ABC (abacavir) to TDF (tenofovir).
Kivexa is a combination HIV pill of Abacavir and lamivudine and Abacavir alone is one of the two drugs in Kivexa. Truvada, another combination pill that contains the drugs tenofovir and emtricitabine and Tenofovir alone is one of the two drugs in Truvada. Truvada and Tenofovir are the two drugs to be used in this study. This is a 24 week study
Truvada dose is 1 x 300mg/200mg tablet, once daily, oral for 24 weeks.
Tenofovir dose is 1 x 300mg tablet, once daily oral for 24 weeks.
Intervention code:Treatment: drugs 
Comparator / control treatment: N/A
Control group: Uncontrolled

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Primary outcome:To evaluate cardiovascular function measured by radial artery applanation tonometry in HIV-infected adults switching from ABC-3TC to TDF-FTC (or from ABC to TDF). 
Timepoint:Baseline and at twenty four weeks 
Secondary outcome:To relate these functional arterial changes to HIV-related, metabolic and pro-inflammatory parameters. This will be done by looking at Tonometry reports done at various timepoints throughout the study as well as pathology blood results 
Timepoint:twenty four weeks after the start of the study. The outcome will be assessed also at weeks 4 and 12. 

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Key inclusion criteria: provision of written, informed consent.
HIV-infected adults at least 18 years of age.
receiving stable antiretroviral therapy including ABC or ABC-3TC for at least six months.
HIV Ribonucleic Acid (RNA) < 50 copies/ml for at least the previous 3 months.
Framingham risk score = 10%, OR diabetes, OR prior ischaemic cardiovascular disease.
Minimum Age: 18 Years
Maximum Age: 200 Years
Gender: Both males and females
Healthy volunteers? Yes
Key exclusion criteria: clinically significant renal or hepatic disease. initiation of anti hypertensive therapy in the previous 30 days. initiation of therapy for dyslipidaemia in the previous 6 weeks. using corticosteroids, anti-inflammatory drugs or immunomodulating drugs. contra-indications to TDF or TDF-FTC therapy (e.g. grade 3 renal dysfunction).

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding:
Who is/are masked/blinded:
Assignment:
Other design features (specify):
Type of endpoint(s):

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Phase Phase 4
Anticipated or actual date of first participant enrolement: 23/09/2008
Target sample size: 20
Recruitment status: Open to recruitment

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Funding source:Hospital 
Name:St Vincents Hospital 
Address:390 Victoria St, Darlinghurst, NSW 2010 
Country:Australia 
Primary sponsor: Hospital
Name: St Vincents Hospital
Address: 390 Victoria St, Darlinghurst, NSW 2010
Country: Australia
Secondary sponsor:None 
Name: 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee: 
Countries of recruitment:Australia 
Brief summary: The purpose is to perform tonometry in HIV-infected adults before and after switching their HIV treatment from Kivexa to Truvada (or from Abacavir to Tenofovir).
Hypothesis: that markers of cardiovascular function (as measured by applanation tonometry) will improve in patients switching from ABC-3TC to TDF-FTC.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Registered Nurse (RN) Kate Sinn
Address: St Vincents Hospital
Level 4 Xavier Bldg
390 Victoria St, Darlinghurst, NSW 2010
Country: Australia
Tel: +61 2 8382 3060
Fax:
Email: ksinn@stvincents.com.au

Contact person for scientific queries
Name: Professor Andrew Carr
Address: St Vincents Hospital
Level 4 Xavier Bldg
390 Victoria St, Darlinghurst, NSW 2010
Country: Australia
Tel: +61 2 8382 3359
Fax:
Email: acarr@stvincents.com.au

Contact person responsible for updating information
Name: RN Robyn Richardson
Address: St Vincents Hospital
Level 4 Xavier Bldg
390 Victoria St, Darlinghurst, NSW 2010
Country: Australia
Tel: +61 2 8382 3872
Fax:
Email: rrichardson1@stvincents.com.au
   
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