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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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12 December 2020 |
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Main ID: |
NCT03120065 |
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Date of registration:
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06/03/2017 |
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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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Virologic Treatment Failure and Drug Resistance in HIV-infected Kenyan Children (RESPECT)
RESPECT |
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Scientific title:
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Virologic Treatment Failure and Drug Resistance in HIV-infected Kenyan Children |
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Date of first enrolment:
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April 24, 2017 |
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Target sample size:
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499 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03120065 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Rachel C Vreeman, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previous enrollment in CAMP study
- Viable banked blood sample; HIV-infected documented by DNA-PCR (Amplicor, Roche,
Basel, Switzerland) for children less than 18 months of age and by 2 parallel HIV
rapid ELISA tests using Determine and Bioline for children older than 18 months of
age.
- < 19 years of age
Exclusion Criteria:
Mental or physical incapacity of legal caregiver leading to inability to provide informed
consent
Age minimum:
4 Years
Age maximum:
19 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Viral Resistance
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Treatment Failure
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Intervention(s)
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Other: Electronic Dose Monitoring (MEMS)
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Primary Outcome(s)
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Viral Resistance
[Time Frame: 18 months]
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Secondary Outcome(s)
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Clinical Data: Viral Load
[Time Frame: 6 years]
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Adherence MEMS
[Time Frame: 3 months]
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Clinical Data: Height
[Time Frame: 6 years]
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Adherence CAMP
[Time Frame: 3 months]
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Clinical Data: WHO stage
[Time Frame: 6 years]
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Clinical Data: Disclosure Status
[Time Frame: 6 years]
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Clinical Data: Opportunistic Infections
[Time Frame: 6 years]
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Clinical Data: Regimen
[Time Frame: 6 years]
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Clinical Data: Weight
[Time Frame: 6 years]
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Secondary ID(s)
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1601396087
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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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