Cardiovascular function with switching from Kivexa to Truvada (or from Abacavir to Tenofovir).

Cardiovascular function with switching from Kivexa to Truvada (or from Abacavir to Tenofovir) in people with Human Immunodeficiency Virus (HIV).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000014257

Acronym

SKiT

Enrollment

Registered

2009-01-08

Start date

2008-09-23

Completion date

2009-05-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 200 Years

Healthy volunteers

Yes

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.

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).

Outcome results