Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000014257
Ethics application status
Approved
Date submitted
14/11/2008
Date registered
8/01/2009
Date last updated
22/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiovascular function with switching from Kivexa to Truvada (or from Abacavir to Tenofovir).
Scientific title
Cardiovascular function with switching from Kivexa to Truvada (or from Abacavir to Tenofovir) in people with Human Immunodeficiency Virus (HIV).
Secondary ID [1] 282896 0
Nil
Universal Trial Number (UTN)
Trial acronym
SKiT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 3982 0
Cardiovascular function 3983 0
Condition category
Condition code
Infection 4180 4180 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
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 [1] 3703 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5070 0
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 [1] 5070 0
Baseline and at twenty four weeks
Secondary outcome [1] 8522 0
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 [1] 8522 0
twenty four weeks after the start of the study.
The outcome will be assessed also at weeks 4 and 12.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
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).

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/09/2008
Actual
23/09/2008
Date of last participant enrolment
Anticipated
Actual
13/05/2009
Date of last data collection
Anticipated
Actual
27/10/2009
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11212 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23086 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 4171 0
Hospital
Name [1] 4171 0
St Vincents Hospital
Country [1] 4171 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital
Address
390 Victoria St, Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 3746 0
None
Name [1] 3746 0
Address [1] 3746 0
Country [1] 3746 0

Ethics approval
Ethics application status
Approved

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29133 0
Prof Andrew Carr
Address 29133 0
St Vincents Hospital
Xavier, Level 4, 390 Victortoria St
Darlinghurst, NSW, 2010
Country 29133 0
Australia
Phone 29133 0
+61 2 83823359
Fax 29133 0
Email 29133 0
[email protected]
Contact person for public queries
Name 12290 0
Ms Registered Nurse (RN) Kate Sinn
Address 12290 0
St Vincents Hospital
Level 4 Xavier Bldg
390 Victoria St, Darlinghurst, NSW 2010
Country 12290 0
Australia
Phone 12290 0
+61 2 8382 3060
Fax 12290 0
Email 12290 0
[email protected]
Contact person for scientific queries
Name 3218 0
Prof Professor Andrew Carr
Address 3218 0
St Vincents Hospital
Level 4 Xavier Bldg
390 Victoria St, Darlinghurst, NSW 2010
Country 3218 0
Australia
Phone 3218 0
+61 2 8382 3359
Fax 3218 0
Email 3218 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
SourceTitleYear of PublicationDOI
Dimensions AIDetrimental clinical interaction between ritonavir-boosted protease inhibitors and vinblastine in HIV-infected patients with Hodgkin's lymphoma2010https://doi.org/10.1097/qad.0b013e32833db989
Dimensions AILower arterial stiffness and Framingham score after switching abacavir to tenofovir in men at high cardiovascular risk2010https://doi.org/10.1097/qad.0b013e32833d568f
Dimensions AIHIV genetic diversity between plasma and cerebrospinal fluid in patients with HIV encephalitis2010https://doi.org/10.1097/qad.0b013e32833e9245
Dimensions AIHIV-1 Gag evolution in recently infected human leukocyte antigen-B*57 patients with low-level viremia2010https://doi.org/10.1097/qad.0b013e32833d8a38
N.B. These documents automatically identified may not have been verified by the study sponsor.