NCT00683579|CompletedDMC
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Sponsor study identifier
observational
220
2 countries
21
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)ATN 071 is a prospective cohort study comparing neurocognitive functioning in four groups of youth, age 18-24: Two groups with CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml, one initiating HAART (Group 1) and the other not initiating treatment (Group 2); and two groups with CD4+ T cells \< 350 cells/mm3, one initiating treatment (Group 3) and the other not initiating treatment (Group 4). Groups 2 and 3 represent standard of care. Group 1 and a portion of group 2 will be co-enrolled in ATN 061 and will be randomly assigned to group by that protocol.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 21, 2008
Actual (reported)May 23, 2008
Actual (reported)June 2013
Actual (reported)June 2013
Actual (reported)The impact of early initiation of HAART on preventing neurocognitive decline in HIV infected adolescents compared to no treatment and initiation following current guidelines.
3 years
Assess youth who meet current DHHS guidelines for initiating HAART but either refuse to start HAART or are not prescribed HAART because of concerns about adherence.
Baseline assessment (not longitudinal)
To assess if de-intensification of HAART as will occur in Arm A of ATN 061 can minimally maintain neurocognitive gains made with one year of HAART.
3 years
To assess the relationship of neurocognitive functioning to CD4+ and viral load at baseline in adolescents with HIV-1 infection (groups 1 and 2 versus 3 and 4).
3 years
To correlate neurocognitive change with changes in CD4+ and viral loads within groups.
3 years
To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.
3 years
Participants with CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml who are initiating HAART with possibility of de-intensification (early treatment).
Participants with CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml who are not initiating treatment.
Participants with CD4+ T cells \< 350 cells/mm3 who are initiating treatment.
Participants with CD4+ T cells \< 350 cells/mm3 who are not initiating treatment.
HAART with possibility of de-intensification
No treatment. For group 2, participants do not yet meet DHHS guidelines. For group 4, treatment is not initiated due to unwillingness or providers' expectation of poor adherence.
English or Spanish speaking youth, 18 years 0 days to 24 years 364 days, with HIV-1 infection acquired after age 9 via behavioral means, in the following immunological and treatment categories: 1. Early initiation of HAART and enrolled in 061 Arm A; CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml; 2. Initiation of HAART per DHHS guidelines (standard of care) but not yet meeting criteria. There will be 25 participants from ATN 061 preferentially enrolled into this protocol; an additional 25 participants will be enrolled with similar biomedical characteristics. 3. Initiation of HAART per DHHS guidelines (not part of ATN 061). 4. Meeting DHHS guidelines for initiating HAART, but not initiating due to unwillingness or providers' expectation of poor adherence.
Children's Hopsital of Los Angeles
Los Angeles, California, 90027, United States
University of Southern California - IMPAACT Site
Los Angeles, California, 90033, United States
University of California at San Francisco
San Francisco, California, 94118, United States
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, 80045, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
Howard University - IMPAACT Site
Washington D.C., District of Columbia, 20060, United States
Children's Diagnostic and Treatment Center
Borkar SA, Yin L, Venturi GM, Shen J, Chang KF, Fischer BM, Nepal U, Raplee ID, Sleasman JW, Goodenow MM. Youth Who Control HIV on Antiretroviral Therapy Display Unique Plasma Biomarkers and Cellular Transcriptome Profiles Including DNA Repair and RNA Processing. Cells. 2025 Feb 15;14(4):285. doi: 10.3390/cells14040285.
Yin L, Venturi GM, Barfield R, Fischer BM, Kim-Chang JJ, Chan C, De Paris K, Goodenow MM, Sleasman JW. Maternal immunity shapes biomarkers of germinal center development in HIV-exposed uninfected infants. Front Immunol. 2024 Sep 12;15:1443886. doi: 10.3389/fimmu.2024.1443886. eCollection 2024.
Sharon Nichols
Adolescent Trials Network
220 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Microbicides Acceptability Among Sexually Active Young Women
Initiation of HAART per DHHS guidelines, i.e. starting treatment and CD4+ T cells less than 350 cells/mm3 or HIV RNA \>100,000 copies/ml
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Fort Lauderdale, Florida, 33316, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University - IMPAACT Site
Baltimore, Maryland, 21287, United States
Children's Hospital of Michigan - IMPAACT Site
Detroit, Michigan, 48201, United States
Mount Sinai Medical Center
Manhattan, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Children's Research Center
Memphis, Tennessee, 38105, United States
St. Jude Children's Research Hospital - IMPAACT Site
Memphis, Tennessee, 38105, United States
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
Kohn JN, Loop MS, Kim-Chang JJ, Garvie PA, Sleasman JW, Fischer B, Rendina HJ, Woods SP, Nichols SL, Hong S. Trajectories of Depressive Symptoms, Neurocognitive Function, and Viral Suppression With Antiretroviral Therapy Among Youth With HIV Over 36 months. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):851-859. doi: 10.1097/QAI.0000000000002653.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
February 28, 2017
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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