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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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25 March 2024 |
Main ID: |
NCT02154035 |
Date of registration:
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31/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans
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Scientific title:
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Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans |
Date of first enrolment:
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May 31, 2014 |
Target sample size:
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90 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02154035 |
Study type:
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Observational |
Study design:
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Phase:
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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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Steven J Reynolds, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
1. At least 18 years of age
2. Hemoglobin >11g/dL as assessed by fingerstick rapid test
3. Weight >40 kilograms
4. A historical diagnosis of HIV infection as indicated by any positive serological
test (ELISA, HIV rapid test, or Western Blot)
5. Virally suppressed as defined as at least two historical viral loads <40
copies/ml obtained between 10-18 months apart, and no intervening detectable
viral load result >= 40 copies/ml obtained during this period
6. Most recent historical viral load result obtained within a year prior to the
screening visit
7. Willingness to undergo genetic testing
EXCLUSION CRITERIA:
1. Women who are pregnant will be excluded as the required blood draw may cause anemia
and because of perturbations due to hormonal or immunosuppressive states that could
impact the reservoir
2. Inability to follow study instructions or to provide informed consent
3. Any condition deemed by the investigators to be a contraindication to study
participation including active, serious infections (other than HIV infection) during
the 2 weeks prior to enrollment
4. Malignancies of any kind (e.g., Kaposi's sarcoma)
5. Therapy with systemic steroids, immunosuppressants or immunomodulating agents
6. Coagulation defects or other serious bleeding disorders
7. Current use of medications which could affect clotting
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Primary Outcome(s)
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Determine the role of endemic infectious diseases, nadir CD4 count, and length of fully suppressive therapy on latent HIV reservoir size
[Time Frame: Enrollment]
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Examine and measure the levels of latent HIV reservoirs in virally suppressed Ugandans and compare to that observed in Western (US) cohorts
[Time Frame: Enrollment]
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Explore the level of immune activation in virally suppressed HIV-infected Africans in correlation with the size of the reservoir
[Time Frame: Enrollment]
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Secondary ID(s)
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14-I-N123
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999914123
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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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