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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: |
NCT00135460 |
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Date of registration:
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25/08/2005 |
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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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Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
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Scientific title:
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Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial. |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00135460 |
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Study type:
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Interventional |
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Study design:
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Allocation: 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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Henrik Nielsen, 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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Aalborg Universitetshospital |
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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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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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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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Alex Laursen, 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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Aarhus University City |
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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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Copenhagen University Hospital Rigshospitalet and Odense University Hospital |
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Name:
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Niels Obel, 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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Odense University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Antiretroviral naïve patients
- HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
- Fulfilling the criteria for starting antiretroviral therapy.
- 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.
- Ongoing medical treatment, which has a clinically significant interaction with
lopinavir, ritonavir or efavirenz.
- 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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HIV-Associated Lipodystrophy Syndrome
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Intervention(s)
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Drug: nucleoside analogue sparing HAART regimen
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Primary Outcome(s)
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Changes in peripheral fat mass, determined by DEXA-changes
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Change from baseline in fasting lipids and subsets hereof
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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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Development of impaired glucose tolerance and insulin resistance
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Secondary Outcome(s)
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Incidence of clinical disease progression
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Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks
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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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Development of osteopenia, judged by DEXA-scan
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Time to discontinuation of the randomized therapy and reasons for this
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Change in plasma lactate from baseline
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Compliance – proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96
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Incidence of adverse events
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Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks
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Incidence of genotypical and virological resistance
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Secondary ID(s)
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2612-2198
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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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