This study aims to investigate whether patients switching their backbone from Kivexa to Truvada, who already have raised total cholesterol prior to switching, have an improvement in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the study aims to show whether this has a beneficial effect on the patient's overall cardiovascular risk and long term prognosis.
This protocol is a Phase 4, open label, randomized, UK multi-center, controlled study to assess the effect on lipid profile of switching from a stable HAART regimen of Kivexa + EFV to once daily Atripla in adult HIV 1 infected subjects with raised cholesterol. At Baseline, subjects will be randomized 1:1 to one of two treatment groups: Treatment Group 1: switch to Atripla Treatment Group 2: Continuation of previous stable HAART regimen of Kivexa + EFV Initiation of treatment with study drugs must take place within 24 hours after Baseline visit. At Week 12, subjects in Treatment Group 2 (continuation of Kivexa and EFV regimen) will switch to Atripla. Treatment in both groups will continue through Week 24
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
Open label once daily for oral administration to be taken on an empty stomach
Open label once daily for oral administration
Gilead Sciences
Granta Park, Cambridge, Abington, United Kingdom
Change from baseline in total fasting cholesterol at Week 12.
Time frame: 12 Weeks
Change in total fasting cholesterol at Week 24
Time frame: 24 fweeks
Changes in fasting LDL, HDL, triglycerides, non-HDL cholesterol and cholesterol ratios
Time frame: 24 weeks
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