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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: |
NCT02689895 |
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Date of registration:
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13/02/2016 |
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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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Etiology of Treatment Failure in HIV Positive Children and Adolescents on Boosted Protease Inhibitor-based Regimens
ATF |
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Scientific title:
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Etiology of Treatment Failure in HIV Positive Children and Adolescents on Boosted Protease Inhibitor-based Regimens |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02689895 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. 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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Zimbabwe
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Contacts
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Name:
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Kusum Nathoo, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe |
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Name:
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Charles FB Nhachi, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe |
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Name:
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Tariro D Chawana, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zimbabwe |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Parents/guardian willing to consent
2. Child willing to provide assent
3. Documented HIV positive antibody or antigen test
4. Child knows their HIV status
5. Aged between 6 and 18 years (that is, from the day of their 6th birthday up to the eve
of their 18th birthday)
6. Registered at Harare hospital paediatric opportunistic infections clinic
7. On second line treatment (ATV/r based)
8. Have taken the above named second line treatment for at least 6 complete, consecutive
months
9. Has virological and immunological treatment failure as defined by WHO 2012 criteria
Exclusion Criteria:
1. Patients registered at other health centres who have been referred for specialist care
at Harare hospital paediatric opportunistic infections clinic
2. On ATV/r as first line treatment
3. Patients who do not want to be followed up at home.
4. On anti-tuberculosis (TB) treatment
Age minimum:
10 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Other: modified directly administered anti-retroviral therapy (mDAART)
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Primary Outcome(s)
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Number of Participants with treatment success described as viral load below 1 000 copies/ml at the end of follow-up.
[Time Frame: 3 months]
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Secondary ID(s)
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ATF study
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1D43TW009539
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2R01AI098472
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2U2RTW007367
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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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