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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00139178 |
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Date of registration:
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30/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.
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Scientific title:
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Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00139178 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Alex Laursen, D.M., DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aarhus University Hospital |
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Name:
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Court Pedersen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital |
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Name:
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Lars Mathiesen, M.D. DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital |
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Name:
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Ann-Brit E Hansen, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital |
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Name:
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Jan Gerstoft, M.D., DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Name:
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Niels Obel |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lipoatrophy
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HIV Associated Lipodystrophy Syndrome.
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HIV
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Hypercholesterolemia
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Intervention(s)
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Drug: Different HAART regimens
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Incidence of adverse events.
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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.
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Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24,48 and 96.
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Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks.
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Incidence of clinical disease progression.
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Change in plasma lactate from baseline.
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Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks.
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Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination.
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Time to discontinuation of the allocated therapy and reasons for this.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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