Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue
Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
Summary
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or
moderate lipoatrophy has shown an increase in limb fat by DEXA. This study was conducted over
a 24-week period and although improved outcomes were documented by objective measures, DEXA
scans, subjective observation did not correspond. Longer-term follow up of these patients is
required.
This 48 week study is designed to compare the substitution of the thymidine analogues
zidovudine (ZDV) or stavudine (D4T) with either tenofovir DF or abacavir, in patients treated
with highly active antiretroviral therapy (HAART), and show improved outcomes on total limb
fat mass, improved body shape by dual energy x-ray absorptiometry (DEXA) and computed
tomography (CT) scans and improved cholesterol and triglycerides.