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Main
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Note: This record shows only the 20 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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25 February 2013 |
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Main ID: |
NCT00978237 |
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Date of registration:
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15/09/2009 |
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Primary sponsor: |
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Public title:
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Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients
LIPOKAL |
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Scientific title:
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CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues. |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00978237 |
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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 Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients HIV positive > 18 years.
- Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
- HIV-ARN < 50 copies/mL in the las six months.
- Clinically evident lipoatrophy (moderate or severe).
- Negative pregnancy test.
- Signed informed consent.
Exclusion Criteria:
- Evidence of failure or mutation to therapy with protease inhibitors.
- Patients that can not be treated with LPV/r.
- Mild lipoatrophy.
- History of alcoholism or drug addiction that discourages participation in the study.
- Pregnancy or breastfeeding.
- Documented current or 4 weeks prior opportunistic infection.
- Creatinin clearance < 60mL/min.
- Concomitant use of nephrotoxic drugs or immunosuppressants.
- Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
- Patients under treatment with other drugs in investigation.
- Acute hepatitis.
- Any other disease that discourages participation.
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 Infections
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Lipoatrophy
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Intervention(s)
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Drug: EFV
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Drug: LPV/r
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Primary Outcome(s)
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Absolute change in limb fat mass measured by DEXA.
[Time Frame: 24 months.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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