Lipodystrophy Clinical Trial
Official title:
A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)
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. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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