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.
Study Type
OBSERVATIONAL
Enrollment
220
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.
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
Children's Hopsital of Los Angeles
Los Angeles, California, United States
The impact of early initiation of HAART on preventing neurocognitive decline in HIV infected adolescents compared to no treatment and initiation following current guidelines.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 3 years
To correlate neurocognitive change with changes in CD4+ and viral loads within groups.
Time frame: 3 years
To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.
Time frame: 3 years
To evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV.
Time frame: 3 years
To assess the relationship of neurocognitive functioning to available biomarkers within the subset of participants co-enrolled in ATN 061 (for example, immune activation markers, viral phenotype, CD4 and CD8 subsets).
Time frame: 3 years
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University of Southern California - IMPAACT Site
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Howard University - IMPAACT Site
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Stroger Hospital of Cook County
Chicago, Illinois, United States
...and 11 more locations