Neurocognitive Assessment in Youth Initiating HAART

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: HAART Treatment - standard care; Other: No treatment; Drug: Early Treatment with HAART

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00683579

ATN 071

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 4 patient groups

1

Description:

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).

Treatment:

Drug: Early Treatment with HAART

2

Description:

Participants with CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml who are not initiating treatment.

Treatment:

Other: No treatment

3

Description:

Participants with CD4+ T cells \< 350 cells/mm3 who are initiating treatment.

Treatment:

Drug: HAART Treatment - standard care

4

Description:

Participants with CD4+ T cells \< 350 cells/mm3 who are not initiating treatment.

Treatment:

Other: No treatment