Brief Title
Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
Official Title
Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities
Brief 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
Condition
HIV Associated Lipodystrophy Syndrome.
Intervention
Different HAART regimens
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
March 2004
Completion Date
April 2007
Eligibility 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).
Gender
All
Ages
18 Years - N/A
Contacts
Jan Gerstoft, M.D., DMSc, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00139178
Organization ID
26122450
Study Sponsor
Danish HIV Research Group
Collaborators
Odense University Hospital
Study Sponsor
Jan Gerstoft, M.D., DMSc, Principal Investigator, Rigshospitalet, Denmark
Verification Date
August 2005