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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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19 February 2015 |
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Main ID: |
NCT00296660 |
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Date of registration:
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24/02/2006 |
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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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Acute HIV Infection Observational Study
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Scientific title:
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Acute HIV-1 Infection Prospective Cohort Study |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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1300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00296660 |
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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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Malawi
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South Africa
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Tanzania
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Uganda
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United States
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Contacts
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Name:
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Myron S. Cohen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medicine, Microbiology, and Immunology and Public Health, Division of Infectious Diseases, University of North Carolina Center for Infectious Diseases |
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Key inclusion & exclusion criteria
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Inclusion Criteria for All Participants:
- Willing to receive HIV test results
- Willing to provide updated locator information during the study
Inclusion Criteria for Group 1:
- Acute HIV infection OR sexual partner of a Group 1 participant with acute HIV
infection
Inclusion Criteria for Group 2:
- Established HIV infection (positive HIV antibody test and positive HIV Western blot)
Inclusion Criteria for Group 3:
- HIV uninfected
Exclusion Criteria for All Participants:
- Plan to relocate out of the area during the study or have a job or other obligations
that may require long absences from the area
- Currently on antiretroviral therapy. Women who previously took antiretroviral therapy
for the prevention of mother-to-child transmission of HIV are not excluded.
- Any other condition that, in the opinion of the investigator, may interfere with the
study
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 Infections
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Primary Outcome(s)
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Clinical, laboratory, and behavioral characteristics of individuals at diverse sites with acute HIV infection and their sexual partners, and appropriate controls
[Time Frame: Throughout study]
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Immune responses contributing to viral control and/or protection against HIV infection
[Time Frame: Throughout study]
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Characteristics of transmitted virus in acute HIV infection
[Time Frame: Throughout study]
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Genetic factors contributing to early virus control and/or protection from HIV infection
[Time Frame: Throughout study]
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Prevalence of acute HIV infection
[Time Frame: Throughout study]
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Secondary ID(s)
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CHAVI 001
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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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