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.
This is a phase II, open-label, multicentre, randomised, two-arm study of 48 weeks duration. One hundred HIV infected individuals who have documented lipodystrophy at \> 1 body/facial site and currently receiving zidovudine (ZDV) or stavudine (d4T) will be recruited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
tenofovir DF 300mg once daily along with the other antiviral drugs
abacavir 300mg twice daily along with the other antiviral drugs
Gilead Sciences
Abingdon, Cambridge, United Kingdom
Change in total limb fat mass by DEXA scan
Time frame: 24 and 48 weeks
Change in VAT by single slice L4 abdominal CT scan
Time frame: 24 and 48 weeks
Change in viral load measurements and CD4 cell count
Time frame: 24 and 48 Weeks
Change in fasting cholesterol and triglycerides
Time frame: 24 and 48 Weeks
Change in blood insulin and fasting glucose
Time frame: 24 and 48 Weeks
Change in blood lactate and anion gap
Time frame: 24 and 48 Weeks
Change in bone mineral density by DEXA scan
Time frame: 24 and 48 Weeks
Incidence of adverse events
Time frame: Upto 48 weeks
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