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Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants (IDX)

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ClinicalTrials.gov Identifier: NCT01222130
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
HIV Infections

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 1126 participants
Time Perspective: Cross-Sectional
Official Title: CIDRZ 1234 - Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants
Study Start Date : July 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected mothers and their exposed infants seek care in a primary care setting in Lusaka, Zambia
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222130


Locations
Zambia
George Health Centre
Lusaka, Zambia, 10101
Kamwala Health Centre
Lusaka, Zambia, 10101
Matero Reference Health Centre
Lusaka, Zambia, 10101
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Elizabeth Glaser Pediatric AIDS Foundation
More Information

Responsible Party: Benjamin Chi, MD, MSc, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01222130     History of Changes
Other Study ID Numbers: MQ-00-6-300-01206-0-00
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill:
HIV
Infant infection
Diagnosis
Non-virological algorithm

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases