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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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2 May 2016 |
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Main ID: |
NCT01450605 |
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Date of registration:
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10/10/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Korean Post-marketing Surveillance for Reyataz®
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Scientific title:
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Korean Post-marketing Surveillance for Reyataz® |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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601 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01450605 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients = 13 years of age with HIV-1 who are on Reyataz® treatment at the time of
enrollment and have never been participated in this study previously or who are
initiating Reyataz® treatment for the first time in the real-life conditions in its
registered indication(s) as required by KFDA
Exclusion Criteria:
- According to Warning/Caution in local label
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV-1
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Intervention(s)
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Drug: No Intervention
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Primary Outcome(s)
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Adverse events occurrence
[Time Frame: 30 days after last dose of study drug]
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Secondary Outcome(s)
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Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration
[Time Frame: Baseline and 16 weeks after first treatment]
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CD 4 T-cell count before and after drug administration
[Time Frame: Baseline and 16 weeks after first treatment]
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Overall efficacy evaluation by investigator's discretion
[Time Frame: Baseline and 16 weeks after first treatment]
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Secondary ID(s)
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AI424-414
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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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