A Phase 2 interventional study of tenofovir disoproxil fumarate and Abacavir in HIV, sponsored by Gilead Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-10.
Sponsored by Gilead Sciences · Phase 2 and Interventional
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 tryglicerides.
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat (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 tryglicerides.
Gilead Sciences is the lead sponsor of 689 studies on the registry; 24 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
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This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abacavir