NCT00139178

Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Danish HIV Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• HIV Associated Lipodystrophy Syndrome.
• HIV
• Hypercholesterolemia
• Lipoatrophy

Interventions

Type	Name	Description
DRUG	Different HAART regimens

Timeline

• Start date: 2004-03-01
• Completion: 2007-04-01
• First posted: 2005-08-31
• Last updated: 2005-09-05

Locations

4 sites across 1 country: Denmark