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The Capital Region of Denmark - a part of Copenhagen University Hospital

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.

Project: Types of projects

  • Gerstoft, Jan, Copenhagen University Hospital Rigshospitalet, Denmark (Project participant)
  • Obel, Niels, Odense University Hospital, Denmark (Project participant)
  • Pedersen, Court, Odense University Hospital, Denmark (Project participant)
  • Mathiesen, Lars Reinhardt (Project participant)
  • Nielsen, Henrik, Aalborg Hospital, Denmark (Project participant)
  • Laursen, Alex, Aarhus University City Hospital, Denmark (Project participant)
  • Hansen, Ann-Brit E., Copenhagen University Hospital Rigshospitalet, Denmark (Project participant)
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Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy. The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen. The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.
StatusCurrent
Period01/06/200330/06/2008
URLhttp://clinicaltrials.gov/ct/show/NCT00135460?order=17
Research programme<ingen navn>

ID: 32505837