Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
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.
|HIV Associated Lipodystrophy Syndrome. HIV Hypercholesterolemia Lipoatrophy||Drug: Different HAART regimens||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities|
- Changes in peripheral fat mass, determined by DEXA-Changes Change from baseline in fasting lipids and subsets hereof. Development of impaired glucose tolerance and insulin resistance.
- Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
- Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.
- Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.
- Incidence of adverse events.
- Incidence of clinical disease progression.
- Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.
- Change in plasma lactate from baseline.
- Time to discontinuation of the allocated therapy and reasons for this.
- Incidence of genotypical and virological resistance. Development of osteopenia, judged by DEXA-scan. Compliance – proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96.
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||April 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139178
|Department of Infectious Diseases, Aarhus University Hospital|
|Aarhus, Denmark, 8200|
|Department of Infectious Diseases, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Department of Infectious Diseases, Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Department of Infectious diseases, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Jan Gerstoft, M.D., DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Ann-Brit E Hansen, M.D.||Odense University Hospital|
|Principal Investigator:||Court Pedersen, Professor||Odense University Hospital|
|Principal Investigator:||Lars Mathiesen, M.D. DMSc||Hvidovre University Hospital|
|Principal Investigator:||Alex Laursen, D.M., DMSc||Aarhus University Hospital|
|Study Chair:||Niels Obel||Odense University Hospital|