Neurocognitive Assessment in Youth Initiating HAART

Completed

Conditions: HIV Infections

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

Registration Number: NCT00683579

Lead Sponsor: University of North Carolina, Chapel Hill

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 220

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.

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Early Treatment with HAART	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).
2	No treatment	Participants with CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml who are not initiating treatment.
3	HAART Treatment - standard care	Participants with CD4+ T cells \< 350 cells/mm3 who are initiating treatment.
4	No treatment	Participants with CD4+ T cells \< 350 cells/mm3 who are not initiating treatment.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.	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 evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV.	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).	3 years

Trial Locations

Locations (21): University of Southern California - IMPAACT Site
🇺🇸
Los Angeles, California, United States
Johns Hopkins University - IMPAACT Site
🇺🇸
Baltimore, Maryland, United States
Childrens Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Children's Hopsital of Los Angeles
🇺🇸
Los Angeles, California, United States
Stroger Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
Childrens Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Children's Diagnostic and Treatment Center
🇺🇸
Fort Lauderdale, Florida, United States
St. Jude Children's Research Center
🇺🇸
Memphis, Tennessee, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Children's Hospital of Denver - IMPAACT Site
🇺🇸
Aurora, Colorado, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
St. Jude Children's Research Hospital - IMPAACT Site
🇺🇸
Memphis, Tennessee, United States
Mount Sinai Medical Center
🇺🇸
Manhattan, New York, United States
University of California at San Francisco
🇺🇸
San Francisco, California, United States
University of Miami School of Medicine
🇺🇸
Miami, Florida, United States
Childrens National Medical Center
🇺🇸
Washington, District of Columbia, United States
Howard University - IMPAACT Site
🇺🇸
Washington, District of Columbia, United States
Tulane University Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States
Children's Hospital of Michigan - IMPAACT Site
🇺🇸
Detroit, Michigan, United States
University of Puerto Rico
🇵🇷
San Juan, Puerto Rico
Montefiore Medical Center
🇺🇸
Bronx, New York, United States

Neurocognitive Assessment in Youth Initiating HAART

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts