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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 2 | Participants with CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000 copies/ml who are not initiating treatment. |
| |
| 3 | Participants with CD4+ T cells < 350 cells/mm3 who are initiating treatment. |
| |
| 4 | Participants with CD4+ T cells < 350 cells/mm3 who are not initiating treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Treatment with HAART | Drug | HAART with possibility of de-intensification |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Groups 1 and 2 (If co-enrolling in ATN 061)
Group 2, enrolled in ATN 071 and not ATN 061
Groups 3 and 4:
Group 3 ONLY:
Group 4 ONLY:
Exclusion Criteria:
Groups 1 and 2:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Nichols | Adolescent Trials Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hopsital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of Southern California - IMPAACT Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39996757 | Derived | 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. | |
| 33587499 |
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| 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. |
|
| 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 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 |
| 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 |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California at San Francisco | San Francisco | California | 94118 | United States |
| Children's Hospital of Denver - IMPAACT Site | Aurora | Colorado | 80045 | United States |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Howard University - IMPAACT Site | Washington D.C. | District of Columbia | 20060 | United States |
| Children's Diagnostic and Treatment Center | Fort Lauderdale | Florida | 33316 | United States |
| University of Miami School of Medicine | Miami | Florida | 33101 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Childrens Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University - IMPAACT Site | Baltimore | Maryland | 21287 | United States |
| Children's Hospital of Michigan - IMPAACT Site | Detroit | Michigan | 48201 | United States |
| Mount Sinai Medical Center | Manhattan | New York | 10128 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| St. Jude Children's Research Center | Memphis | Tennessee | 38105 | United States |
| St. Jude Children's Research Hospital - IMPAACT Site | Memphis | Tennessee | 38105 | United States |
| University of Puerto Rico | San Juan | 00936-5067 | Puerto Rico |
| 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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