Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
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|ClinicalTrials.gov Identifier: NCT00139178|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : September 5, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Associated Lipodystrophy Syndrome. HIV Hypercholesterolemia Lipoatrophy||Drug: Different HAART regimens||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities|
|Study Start Date :||March 2004|
|Study Completion Date :||April 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|