Neurocognitive Assessment in Youth Initiating HAART



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 24
Updated:3/1/2017
Start Date:December 2007
End Date:June 2013

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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.


Inclusion Criteria:

Groups 1 and 2 (If co-enrolling in ATN 061)

- HIV positive participants age 18 years and 0 days to 24 years and 364 days (the lower
age limit of this study is driven by the restriction of ATZ use to age 18 and
greater);

- Groups 1 and 2: CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000 copies/ml, as
determined by two consecutive measures within 6 months of entry with the second
measure being collected at pre-entry to ATN 061;

- Infected with HIV after the age of nine via behavioral means;

- Naïve to ART except for HAART for PMTCT for six months or less with at least six
months since the time of exposure;

- HIV genotype without major resistance mutations to the recommended ATV-r based HAART
regimens;

- Able to provide written informed consent as determined by local Institutional Review
Boards;

- Fluent in English or Spanish.

Group 2, enrolled in ATN 071 and not ATN 061

- CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000 copies/ml, as determined by most
recent laboratory evaluations available within 4 months prior to entry;

- Not prescribed HAART according to DHHS guidelines.

Groups 3 and 4:

- HIV positive participants age 18 years and 0 days to 24 years and 364 days;

- Infected with HIV after the of age nine via behavioral means;

- Naïve to ART except for HAART for PMTCT for six months or less with at least six
months since the time of exposure;

- Able to provide written informed consent as determined by local Institutional Review
Boards;

- Fluent in English or Spanish.

- CD4+ T cells < 350 cells/mm3, as determined by most recent laboratory evaluations
available within 4 months prior to entry.

Group 3 ONLY:

- Participant initiating HAART.

Group 4 ONLY:

- HAART has not been prescribed due to either participant's refusal to initiate HAART
or provider's concerns about participant's predicted inability to adhere to regimen.

Exclusion Criteria:

Groups 1 and 2:

- For Groups 1 and 2: any history of an AIDS-defining illness;

- Active drug or alcohol use or dependence that, in the opinion of the site personnel,
would interfere with meeting study requirements;

- History of cognitive or motor impairment due to non-HIV-related conditions (for
example, prematurity, cerebral palsy, closed head injury, CNS cancer or cranial
irradiation, etc.) or psychosis. Youth with diagnoses of learning disabilities or
attention deficit hyperactivity disorder will be allowed in the study;

- Enrollment of youth with chronic or acute medical conditions other than HIV that
could potentially impact upon neurocognitive functioning requires protocol chair
approval.

- Pregnancy at any time during the study including entry.
We found this trial at
21
sites
Chicago, Illinois 60614
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1401 South Federal Highway
Fort Lauderdale, Florida 33301
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Aurora, CO
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Baltimore, Maryland 21287
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Chicago, Illinois 60612
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Los Angeles, California 90027
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Los Angeles, California 90033
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Manhattan, New York 10128
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Memphis, Tennessee 38105
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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San Francisco, California 94143
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San Juan, 36506
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington, District of Columbia 20060
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