This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate \[DF\]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice daily fixed dose combination of Combivir.
The success of HAART is largely dependant on an individual's ability to adhere strictly to an antiretroviral regimen. Regimen characteristics that affect adherence include dosing frequency and pill burden. Several studies have shown improved adherence with lower pill burden and a meta-analysis of the virological outcome in relation to pill burden has shown a significant correlation between lower pill burden and better virological outcome. A systematic review of studies across a range of medical specialties demonstrated that once daily therapy improves adherence relative to more frequent dosing although statistical significance was not demonstrated relative to twice daily regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Gilead Sciences
Cambridge, United Kingdom
The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.
The secondary endpoints in this study include: Change from baseline in absolute haemoglobin at Week 48
Lipids profile: change from baseline in total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), TC/HDL, and triglyceride (TG)
Quality of life (QoL)
Measures of treatment adherence (Medication Adherence Self-Report Survey [MASRI] questionnaire)
Measures of regimen intrusiveness (HIS and Brief Medication Questionnaire [BMQ])
Changes in markers of body composition from dual energy x-ray absorptiometry (DEXA) scans (a sub-study)
HIV RNA: proportion of patients with HIV ribonucleic acid (RNA) < 400 copies/mL; proportion of patients with HIV RNA < 50 copies/mL and change from baseline in log10 copies/mL at Weeks 24 and 48
CD4: change from baseline in CD4 counts
Treatment adherence and acceptability
Use of lipid lowering drugs (number of patients and duration of use)
Adverse events (AEs): AEs will be coded and the coded terms will be used to summarize the count of patients with any event, intensity of each event (highest intensity will be used if an event is reported more than once by a patient) and relationship to:
Other lab tests: results at baseline and changes from baseline
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