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

This study has been completed.
Sponsor:
Collaborator:
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by (Responsible Party):
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01222130
First received: October 14, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1126
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 60 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222130

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

No publications provided

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
Study First Received: October 14, 2010
Last Updated: May 30, 2012
Health Authority: Zambia: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 16, 2014