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Clinical Trial 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.

The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy.

We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir).

The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir.

The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00139178
Study type Interventional
Source Danish HIV Research Group
Contact
Status Completed
Phase Phase 4
Start date March 2004
Completion date April 2007

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