A Randomized, Controlled, Open-Label, 48-Week Study of Continuing Successfully Suppressive Treatment in HIV-1 Infected Adults With First-Line Twice-Daily Zidovudine and Lamivudine-Based Regimens Versus Pro-actively Replacing of Zidovudine and Lamivudine by Once-Daily Emtricitabine and Tenofovir Disoproxil Fumarate to Prevent Progression of or Reverse Peripheral Lipoatrophy.
Sponsor study identifier
Secondary identifiers
interventional
120
1 country
1
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2008
Actual (reported)The main objective of the study is to assess changes in fat distribution over 48 weeks of treatment in patients who currently successfully use zidovudine (AZT) and lamivudine (3TC) as part of their regimen and who will either continue these antiretrovirals or who will switch these antiretrovirals to tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Each of these medications is commonly used for the treatment of HIV-1 infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 17, 2006
Actual (reported)October 18, 2006
Actual (reported)October 2008
Actual (reported)Difference between the continuation arm and the switch arm in:
changes in subcutaneous and visceral abdominal fat by CT and truncal fat by whole body DEXA over 48 weeks
changes in lipids (total-, HDL-, and LDL-cholesterol, total /HDL cholesterol ratio, triglycerides), and glucose-metabolism (glucose, insulin) and insulin resistance (HOMA-index1) over 48 weeks.
incidence of new onset of lipodystrophy and changes in lipodystrophy severity according to the LDCD score.
changes in bone mineral density by regional DEXA (vertebra L4 and femoral neck) over 48 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Academic Medical Centre
Amsterdam, Netherlands
Cotter AG, Vrouenraets SM, Brady JJ, Wit FW, Fux CA, Furrer H, Brinkman K, Sabin CA, Reiss P, Mallon PW; PREPARE (Preventing Progression of Adipose Tissue Redistribution) Investigators. Impact of switching from zidovudine to tenofovir disoproxil fumarate on bone mineral density and markers of bone metabolism in virologically suppressed HIV-1 infected patients; a substudy of the PREPARE study. J Clin Endocrinol Metab. 2013 Apr;98(4):1659-66. doi: 10.1210/jc.2012-3686. Epub 2013 Feb 22.
Peter Reiss, MD, PhD
Academic Medical Centre
First Submitted
October 17, 2006
First Posted
October 18, 2006
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
October 2008
Actual (reported)Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients
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Last Updated
June 11, 2010
Record last verified: 2010-06
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Source: ClinicalTrials.gov.
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