HIV InfectionsNCT00683579
Neurocognitive Assessment in Youth Initiating HAART
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 21 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Early Treatment with HAART and No treatment
- How many people
- 220 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Dec 2007to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University - IMPAACT Site
Baltimore, Maryland, 21287
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Childrens Memorial Hospital
Chicago, Illinois, 60614
Children's Hospital of Michigan - IMPAACT Site
Detroit, Michigan, 48201
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
University of Southern California - IMPAACT Site
Los Angeles, California, 90033
Mount Sinai Medical Center
Manhattan, New York, 10128
St. Jude Children's Research Center
Memphis, Tennessee, 38105
St. Jude Children's Research Hospital - IMPAACT Site
Memphis, Tennessee, 38105
University of Miami School of Medicine
Miami, Florida, 33101
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California at San Francisco
San Francisco, California, 94118
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
Howard University - IMPAACT Site
Washington D.C., District of Columbia, 20060
About this study
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
- Being tested
- Early Treatment with HAART, No treatment, HAART Treatment - standard care
- Keywords
- HAART, DHHS guidelines, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Treatment with HAARTDrug
HAART with possibility of de-intensification
No treatmentOther
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 careDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: No treatment | |
| 3 | Participants with CD4+ T cells < 350 cells/mm3 who are initiating treatment. Receives: Drug: HAART Treatment - standard care | |
| 4 | Participants with CD4+ T cells < 350 cells/mm3 who are not initiating treatment. Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of early initiation of HAART on preventing neurocognitive decline in HIV infected adolescents compared to no treatment and initiation following current guidelines.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 3 years
To correlate neurocognitive change with changes in CD4+ and viral loads within groups.
Measured: 3 years
To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.
Measured: 3 years
To evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV.
Measured: 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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sharon Nichols, Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683579
- Sponsor's protocol ID
- ATN 071
- Status last verified
- Feb 2016
- First submitted
- 21 May 2008
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39996757Yin L, Venturi GM, Barfield R, Fischer BM, Kim-Chang JJ, Chan C, De Paris K, Goodenow MM, Sleasman JW. Maternal immunity shapes biomarkers of germinal center development in HIV-exposed uninfected infants. Front Immunol. 2024 Sep 12;15:1443886. doi: 10.3389/fimmu.2024.1443886. eCollection 2024.
PubMed 39328414Kohn 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.
PubMed 33587499
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Assessment in Youth Initiating HAART
- ClinicalTrials.gov ID
- NCT00683579
- Acronym / sponsor ID
- ATN 071
- Conditions
- HIV Infections
- Keywords
- HAART, DHHS guidelines, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Dec 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Early Treatment with HAARTParticipants 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 | – | Other: No treatmentParticipants with CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000 copies/ml who are not initiating treatment. |
| 3 | – | Drug: HAART Treatment - standard careParticipants with CD4+ T cells < 350 cells/mm3 who are initiating treatment. |
| 4 | – | Other: No treatmentParticipants with CD4+ T cells < 350 cells/mm3 who are not initiating treatment. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (22 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Treatment with HAARTHAART with possibility of de-intensification | Drug | 1 |
| No treatmentNo 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. | Other | 2, 4 |
| HAART Treatment - standard careInitiation 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 | Drug | 3 |
Primary outcome
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
7 secondary outcomes
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)
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
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
To correlate neurocognitive change with changes in CD4+ and viral loads within groups.
Time frame: 3 years
To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.
Time frame: 3 years
To evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV.
Time frame: 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).
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Derived from this study: PubMed 39996757Borkar 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.
- Derived from this study: PubMed 39328414Yin L, Venturi GM, Barfield R, Fischer BM, Kim-Chang JJ, Chan C, De Paris K, Goodenow MM, Sleasman JW. Maternal immunity shapes biomarkers of germinal center development in HIV-exposed uninfected infants. Front Immunol. 2024 Sep 12;15:1443886. doi: 10.3389/fimmu.2024.1443886. eCollection 2024.
- Derived from this study: PubMed 33587499Kohn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Nichols study chair
Adolescent Trials Network
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.