## Protocol Section
### Identification Module
**NCT ID:** NCT00683579

**Brief Title:** Neurocognitive Assessment in Youth Initiating HAART

**Official Title:** Neurocognitive Assessment in Youth Initiating HAART

#### Organization Study ID Info
**ID:** ATN 071
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2013-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-02-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-06

**Type:** ACTUAL

#### Start Date
**Date:** 2007-12

**Status Verified Date:** 2016-02

#### Study First Post Date
**Date:** 2008-05-23
**Type:** ESTIMATED
**Study First Submit Date:** 2008-05-21
**Study First Submit QC Date:** 2008-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- HIV Infections

**Keywords:**

- HAART

- DHHS guidelines

- Treatment Naive

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 220

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 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).

**Intervention Names:**

- Drug: Early Treatment with HAART

**Label:** 1

#### Arm Group 2

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

**Intervention Names:**

- Other: No treatment

**Label:** 2

#### Arm Group 3

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

**Intervention Names:**

- Drug: HAART Treatment - standard care

**Label:** 3

#### Arm Group 4

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

**Intervention Names:**

- Other: No treatment

**Label:** 4

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** HAART with possibility of de-intensification

**Name:** Early Treatment with HAART

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2

- 4

**Description:** 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.

**Name:** No treatment

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- 3

**Description:** 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

**Name:** HAART Treatment - standard care

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The impact of early initiation of HAART on preventing neurocognitive decline in HIV infected adolescents compared to no treatment and initiation following current guidelines.

**Time Frame:** 3 years

#### Secondary Outcomes

**Measure:** 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.

**Time Frame:** Baseline assessment (not longitudinal)

**Measure:** 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.

**Time Frame:** 3 years

**Measure:** 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).

**Time Frame:** 3 years

**Measure:** To correlate neurocognitive change with changes in CD4+ and viral loads within groups.

**Time Frame:** 3 years

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

**Time Frame:** 3 years

**Measure:** To evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV.

**Time Frame:** 3 years

**Measure:** 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).

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 24 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Children's Hopsital of Los Angeles

**State:** California

**Zip:** 90027

**Location 2:**

**City:** Los Angeles

**Country:** United States

**Facility:** University of Southern California - IMPAACT Site

**State:** California

**Zip:** 90033

**Location 3:**

**City:** San Francisco

**Country:** United States

**Facility:** University of California at San Francisco

**State:** California

**Zip:** 94118

**Location 4:**

**City:** Aurora

**Country:** United States

**Facility:** Children's Hospital of Denver - IMPAACT Site

**State:** Colorado

**Zip:** 80045

**Location 5:**

**City:** Washington

**Country:** United States

**Facility:** Childrens National Medical Center

**State:** District of Columbia

**Zip:** 20010

**Location 6:**

**City:** Washington

**Country:** United States

**Facility:** Howard University - IMPAACT Site

**State:** District of Columbia

**Zip:** 20060

**Location 7:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** Children's Diagnostic and Treatment Center

**State:** Florida

**Zip:** 33316

**Location 8:**

**City:** Miami

**Country:** United States

**Facility:** University of Miami School of Medicine

**State:** Florida

**Zip:** 33101

**Location 9:**

**City:** Tampa

**Country:** United States

**Facility:** University of South Florida

**State:** Florida

**Zip:** 33606

**Location 10:**

**City:** Chicago

**Country:** United States

**Facility:** Stroger Hospital of Cook County

**State:** Illinois

**Zip:** 60612

**Location 11:**

**City:** Chicago

**Country:** United States

**Facility:** Childrens Memorial Hospital

**State:** Illinois

**Zip:** 60614

**Location 12:**

**City:** New Orleans

**Country:** United States

**Facility:** Tulane University Health Sciences Center

**State:** Louisiana

**Zip:** 70112

**Location 13:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland

**State:** Maryland

**Zip:** 21201

**Location 14:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins University - IMPAACT Site

**State:** Maryland

**Zip:** 21287

**Location 15:**

**City:** Detroit

**Country:** United States

**Facility:** Children's Hospital of Michigan - IMPAACT Site

**State:** Michigan

**Zip:** 48201

**Location 16:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10467

**Location 17:**

**City:** Manhattan

**Country:** United States

**Facility:** Mount Sinai Medical Center

**State:** New York

**Zip:** 10128

**Location 18:**

**City:** Philadelphia

**Country:** United States

**Facility:** Childrens Hospital of Philadelphia

**State:** Pennsylvania

**Zip:** 19104

**Location 19:**

**City:** Memphis

**Country:** United States

**Facility:** St. Jude Children's Research Center

**State:** Tennessee

**Zip:** 38105

**Location 20:**

**City:** Memphis

**Country:** United States

**Facility:** St. Jude Children's Research Hospital - IMPAACT Site

**State:** Tennessee

**Zip:** 38105

**Location 21:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** University of Puerto Rico

**Zip:** 00936-5067

#### Overall Officials

**Official 1:**

**Affiliation:** Adolescent Trials Network

**Name:** Sharon Nichols

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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 Section

### Condition Browse Module - Ancestors

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV Infections

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015658

- Term: HIV Infections

### Misc Info Module

- Version Holder: 2024-05-24
