Neurocognitive Assessment in Youth Initiating HAART

HIV Infections Clinical Trial

Official title:

Neurocognitive Assessment in Youth Initiating HAART

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683579
• Other study ID #: ATN 071
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: February 27, 2017
• Start date: December 2007
• Est. completion date: June 2013

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Early Treatment with HAART
HAART with possibility of de-intensification

Other:
• No treatment
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.

Drug:
• HAART Treatment - standard care
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

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	To correlate neurocognitive change with changes in CD4+ and viral loads within groups.		3 years
Secondary	To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.		3 years
Secondary	To evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV.		3 years
Secondary	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