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

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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