Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
NCT ID: NCT00139178
Last Updated: 2005-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2004-03-31
2007-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Different HAART regimens
Eligibility Criteria
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Inclusion Criteria
* Viral load \< 200 copies/ml
* Ability to understand and provide written informed consent.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Hvidovre University Hospital
OTHER
Aarhus University Hospital
OTHER
Danish HIV Research Group
OTHER
Principal Investigators
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Jan Gerstoft, M.D., DMSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Ann-Brit E Hansen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Court Pedersen, Professor
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Lars Mathiesen, M.D. DMSc
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Alex Laursen, D.M., DMSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Niels Obel
Role: STUDY_CHAIR
Odense University Hospital
Locations
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Department of Infectious Diseases, Aarhus University Hospital
Aarhus, , Denmark
Department of Infectious Diseases, Rigshospitalet
Copenhagen, , Denmark
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, , Denmark
Department of Infectious diseases, Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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26122450
Identifier Type: -
Identifier Source: org_study_id