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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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17 October 2012 |
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Main ID: |
NCT01074931 |
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Date of registration:
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22/02/2010 |
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Primary sponsor: |
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Public title:
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Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China
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Scientific title:
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Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China: A Multicenter Post-Marketing Observational Study |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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98 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01074931 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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China
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Contacts
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Name:
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Jian LI, 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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Abbott China |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients infected by HIV-1 who are over 18 years old
- Patients who belong to one of the following cohorts:
- Antiretroviral naïve patients
- Antiretroviral experienced patients, irrespective to their immune and viral
status and current antiretroviral therapy
Exclusion Criteria:
- Patients who have been treated with lopinavir/ritonavir
- Patients who are being treated or will be treated with drugs at risk of interactions
with lopinavir/ritonavir
- Patients who are not tolerant to lopinavir/ritonavir
- Patients who have uncontrolled AIDS defining disease
- Patients participating in another clinical trial
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-1 Infections
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Intervention(s)
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Drug: Lopinavir/ritonavir (Kaletra)
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Primary Outcome(s)
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Evolution of CD4 Count
[Time Frame: Month 3, 6, 12, 18]
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Evolution of the HIV Viral Response
[Time Frame: Month 3, 6, 12, 18]
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Evolution of the Tolerance Issues
[Time Frame: Month 3, 6, 12, 18]
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Secondary Outcome(s)
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Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
[Time Frame: Month 3, 6, 12, 18]
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Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
[Time Frame: Month 3, 6, 12, 18]
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The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment
[Time Frame: Month 3, 6, 12, 18]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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