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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4

Details

• Lead Sponsor: Danish HIV Research Group
• Collaborators: Aarhus University Hospital; Hvidovre University Hospital; Odense University Hospital; Rigshospitalet, Denmark
• Treatments: Abacavir; Lamivudine; Lopinavir; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• Currently treated with lamivudine, zidovudine and abacavir

• Viral load < 200 copies/ml

• Ability to understand and provide written informed consent.

Exclusion Criteria:

• Women being pregnant or breast-feeding.

• Fertile women using no safe contraception.

• Patients with active intravenous drug use.

• Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.

• Creatinine > 200 mmol/l.

• ALT or AST > 5 times upper normal value (200U/l).