CompletedPhase 4ACTRN12609000014257

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).


Sponsor

St Vincents Hospital

Enrollment

20 participants

Start Date

Sep 23, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 200 Yearss

Inclusion Criteria5

  • 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 Criteria5

  • 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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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

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.


Locations(1)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12609000014257


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