Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
Status:
Unknown status
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Danish HIV Research Group
Collaborators:
Aalborg Universitetshospital Aalborg University Hospital Aarhus University Hospital Abbott Hvidovre University Hospital Odense University Hospital Rigshospitalet, Denmark