Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants (IDX)
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ClinicalTrials.gov Identifier: NCT01222130
Recruitment Status :
First Posted : October 18, 2010
Last Update Posted : September 18, 2014
University of North Carolina, Chapel Hill
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by (Responsible Party):
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
This study is designed to develop and evaluate a set of non-virologic diagnostic algorithms to monitor HIV-exposed children of unknown infection status for treatment eligibility during the first year of life. The results of this cross sectional study are expected to be used in development of a series of non-virologic algorithms to determining treatment eligibility among HIV-exposed children in settings where polymerase chain reaction (PCR) testing is not available and to guide the judicious use of PCR testing among HIV-exposed children in settings where PCR is available. These results will directly inform program implementation in Zambia.
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 ]
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Ages Eligible for Study:
up to 60 Weeks (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HIV-infected mothers and their exposed infants seek care in a primary care setting in Lusaka, Zambia
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
infants accompanied by someone other than the mother