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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: |
NCT00646984 |
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Date of registration:
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26/03/2008 |
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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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Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
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Scientific title:
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Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy. |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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147 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00646984 |
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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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Spain
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Contacts
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Name:
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Jose M Gatell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Clinic of Barcelona |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV-infected patients
- On stable antiretroviral therapy
- Viral load below 200 copies/ml
- CD4 above 450 cells/mcl during last 3 months
Exclusion Criteria:
- Weight variation higher than 10% compared with previous stable weight
- Active (CDC-C) opportunistic events
- Major depression or schizophrenia under psychiatric treatment
- Lack of clinical stability
- Pregnant women or planning pregnancy
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: CD-4 guided therapy interruption
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Drug: Standard continuous antiretroviral therapy
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Drug: Viral load driven treatment interruption
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Primary Outcome(s)
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Limb fat content measured by dual X-ray absorptiometry
[Time Frame: 96 weekks]
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Secondary Outcome(s)
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Other body composition analyses
[Time Frame: 96 weeks]
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Secondary ID(s)
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AEM 01-0480
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TARV-DEM-LD
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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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