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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01222130
Date of registration: 14/10/2010
Prospective Registration: No
Primary sponsor: University of North Carolina, Chapel Hill
Public title: Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants IDX
Scientific title: CIDRZ 1234 - Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants
Date of first enrolment: July 2009
Target sample size: 1126
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01222130
Study type:  Observational
Study design:  Time Perspective: Cross-Sectional  
Phase:  N/A
Countries of recruitment
Zambia
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- mother with documented HIV infections

- mother willing to give informed consent for participation

- mother willing to allow child to participant in the study

- infant equal or less than 60 weeks of age

Exclusion Criteria:

- infants accompanied by someone other than the mother

- infants already received antiretroviral therapy



Age minimum: N/A
Age maximum: 60 Weeks
Gender: Both
Health Condition(s) or Problem(s) studied
HIV Infections
Intervention(s)
Primary Outcome(s)
performance (i.e., sensitivity, specificity, negative and positive predictive value) of different algorithms in predicting virologically confirmed HIV infection [Time Frame: within first 12 months of life]
Secondary Outcome(s)
Secondary ID(s)
MQ-00-6-300-01206-0-00
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Elizabeth Glaser Pediatric AIDS Foundation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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