NCT00103883|Completed
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Sponsor study identifier
observational
440
2 countries
15
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2007
Actual (reported)Study Completion
March 2007
Actual (reported)Identifying young people with early HIV-1 infection is important for increasing linkage to care, for behavioral counseling, and for enrolling individuals into programs that can provide effective interventions to disease progression and improve outcome. This study will develop and evaluate a saliva-based sensitive/less sensitive (S/LS) assay for differentiating persons with recent HIV-1 infection (less than 133 days) from those with established HIV-1 infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 15, 2005
Actual (reported)February 16, 2005
Actual (reported)March 2007
Actual (reported)March 2007
Actual (reported)Phase I - Serum-based S/LS assay result
To develop and calibrate a saliva S/LS assay using the FDA licensed OraSure collection device in conjunction with its matched saliva EIA assay to differentiate persons with recent versus established HIV infection (Phase I)
15-20 Months
Phase II - Saliva-based S/LS assay result
To assess that the saliva S/LS method performs equivalently to the reference serum S/LS method for HIV incidence estimates in populations of youth (Phase II)
15-20 Months
HIV infected teens who are referred to or engaged in care at any of the 15 ATN clinical sites during the course of the study.
Youth who test HIV positive at ATN-managed or ATN-affiliated HIV Counseling and Testing Sites (CTS) during the course of the study.
Youth who test HIV positive at the BCHD STD Clinic during the course of the study.
Two hundred fifty subjects will be recruited from the fifteen sites of the Adolescent Trials Network for HIV/AIDS Interventions (ATN) and 190 from the BCHD STD Clinic, a sexually transmitted disease clinic of the Baltimore City Health Department (BCHD). The age range for subjects from the ATN clinical sites will be 12 through 24 years and those from the BCHD STD Clinic will be 17 through 30 years.
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Diego
San Diego, California, 92103, United States
University of California at San Francisco
San Francisco, California, 94118, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami
Miami, Florida, 33101, United States
University of South Florida
Phenotypic and genotypic testing for antiretroviral drug (ART) resistance will be done on stored samples from all subjects who are identified as recently infected by the serum based DV S/LS reference method. An assay for viral replication fitness will also be done on these same samples. This testing will provide a recent assessment of prevalence of transmitted ART resistant HIV-1 in this population.
Ligia Peralta, MD
University of Maryland
440 participants (actual enrollment reported by the registry).
First Submitted
February 15, 2005
First Posted
February 16, 2005
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Typology of Adherence in Adolescents: Phase II
Contact the study team to confirm eligibility.
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland Medical School
Baltimore, Maryland, 21201, United States
Childrens Hospital Boston
Boston, Massachusetts, 02115, United States
Mount Sinai Hospital
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University Pediatric Hospital
San Juan, 00936, Puerto Rico
Primary Completion
March 2007
Actual (reported)Study Completion
March 2007
Actual (reported)Last Updated
March 1, 2017
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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