Neurocognitive Assessment in Youth Initiating HAART

NCT00683579 | Completed DMC

• 1 other identifier: ATN 071
• Study Type: observational
• Target: 220
• Locations: 2 countries
• Sites: 21

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.

Conditions

HIV Infections

Keywords

HAART; DHHS guidelines; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.

  3 years

Study Arms (4)

1

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).

Drug: Early Treatment with HAART

2

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

Other: No treatment

3

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

Drug: HAART Treatment - standard care

4

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

Other: No treatment

Interventions

Early Treatment with HAART DRUG

HAART with possibility of de-intensification

1

No treatment OTHER

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.

2; 4

HAART Treatment - standard care DRUG

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

3

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

English or Spanish speaking youth, 18 years 0 days to 24 years 364 days, with HIV-1 infection acquired after age 9 via behavioral means, in the following immunological and treatment categories: 1. Early initiation of HAART and enrolled in 061 Arm A; CD4+ T cells above 350 cells/mm3 and HIV RNA \>1,000 copies/ml; 2. Initiation of HAART per DHHS guidelines (standard of care) but not yet meeting criteria. There will be 25 participants from ATN 061 preferentially enrolled into this protocol; an additional 25 participants will be enrolled with similar biomedical characteristics. 3. Initiation of HAART per DHHS guidelines (not part of ATN 061). 4. Meeting DHHS guidelines for initiating HAART, but not initiating due to unwillingness or providers' expectation of poor adherence.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (21)

Children's Hopsital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of Southern California - IMPAACT Site

Los Angeles, California, 90033, United States

Location

University of California at San Francisco

San Francisco, California, 94118, United States

Location

Children's Hospital of Denver - IMPAACT Site

Aurora, Colorado, 80045, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Howard University - IMPAACT Site

Washington D.C., District of Columbia, 20060, United States

Location

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University - IMPAACT Site

Baltimore, Maryland, 21287, United States

Location

Children's Hospital of Michigan - IMPAACT Site

Detroit, Michigan, 48201, United States

Location

Mount Sinai Medical Center

Manhattan, New York, 10128, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Center

Memphis, Tennessee, 38105, United States

Location

St. Jude Children's Research Hospital - IMPAACT Site

Memphis, Tennessee, 38105, United States

Location

University of Puerto Rico

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (2)

• Borkar SA, Yin L, Venturi GM, Shen J, Chang KF, Fischer BM, Nepal U, Raplee ID, Sleasman JW, Goodenow MM. Youth Who Control HIV on Antiretroviral Therapy Display Unique Plasma Biomarkers and Cellular Transcriptome Profiles Including DNA Repair and RNA Processing. Cells. 2025 Feb 15;14(4):285. doi: 10.3390/cells14040285.

  PMID: 39996757 DERIVED

• Kohn JN, Loop MS, Kim-Chang JJ, Garvie PA, Sleasman JW, Fischer B, Rendina HJ, Woods SP, Nichols SL, Hong S. Trajectories of Depressive Symptoms, Neurocognitive Function, and Viral Suppression With Antiretroviral Therapy Among Youth With HIV Over 36 months. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):851-859. doi: 10.1097/QAI.0000000000002653.

  PMID: 33587499 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Sharon Nichols

  Adolescent Trials Network

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 28, 2017

Record last verified: 2016-02

Locations

US (20); PR (1)