Status:
COMPLETED
Neurocognitive Assessment in Youth Initiating HAART
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Eligibility:
All Genders
18-24 years
Brief Summary
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 initi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00683579
Start Date
December 1 2007
End Date
June 1 2013
Last Update
February 28 2017
Active Locations (21)
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1
Children's Hopsital of Los Angeles
Los Angeles, California, United States, 90027
2
University of Southern California - IMPAACT Site
Los Angeles, California, United States, 90033
3
University of California at San Francisco
San Francisco, California, United States, 94118
4
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, United States, 80045