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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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10 August 2015 |
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Main ID: |
NCT02514707 |
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Date of registration:
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28/07/2015 |
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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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Outcomes of HIV Infected Individuals After Ten Years on Antiretroviral Treatment
ART Long Term |
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Scientific title:
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Outcomes of HIV Infected Individuals After Ten Years on Antiretroviral Treatment |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02514707 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, 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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Uganda
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Contacts
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Name:
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Barbara Castelnuovo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Infectious Diseases Institute |
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Name:
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Barbara Castelnuovo, MD, PhD |
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Address:
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Telephone:
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+256-312-307000 |
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Email:
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bcastelnuovo@idi.co.ug |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age >18 years
2. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legal representative) has been informed of all pertinent aspects of
the study.
3. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
4. On the 10th consecutive year on ART (any combination including second line)
Exclusion Criteria:
1. ART started before registration in the IDI clinic
2. Subjects enrolled in an experimental 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/AIDS
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Primary Outcome(s)
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Characterize the clinical profile of patients (CD4 cell count, viral loads, WHO state, history of OIs, previous use of ART, level of anemia, and other medical conditions, drug mutations)
[Time Frame: Baseline]
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Drug toxicity as any grade 3 & 4 DAD Scale
[Time Frame: Yearly for 10years]
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Causes of mortality
[Time Frame: Yearly for 10years]
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Secondary Outcome(s)
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Variation of drug levels due to drug-drug interaction
[Time Frame: Yearly for 10years]
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Composite measure of change in Sexual Behavior over time
[Time Frame: Yearly for 10years]
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Cost Analysis
[Time Frame: Yearly for 10years]
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Secondary ID(s)
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ST/0113/15
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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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