Neurocognitive Assessment in Youth Initiating HAART

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00683579
First received: May 21, 2008
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Early Treatment with HAART
Other: No treatment
Drug: HAART Treatment - standard care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Assessment in Youth Initiating HAART

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To correlate neurocognitive change with changes in CD4+ and viral loads within groups. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the relationship of current substance abuse to neurocognitive deficits in youth with risk-acquired HIV. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: December 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
HAART with possibility of de-intensification
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
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.
3
Participants with CD4+ T cells < 350 cells/mm3 who are initiating treatment.
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
4
Participants with CD4+ T cells < 350 cells/mm3 who are not initiating treatment.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683579

Locations
United States, California
Children's Hopsital of Los Angeles
Los Angeles, California, United States, 90027
University of Southern California - IMPAACT Site
Los Angeles, California, United States, 90033
University of California at San Francisco
San Francisco, California, United States, 94118
United States, Colorado
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, United States, 80045
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States, 20010
Howard University - IMPAACT Site
Washington, District of Columbia, United States, 20060
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami School of Medicine
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins University - IMPAACT Site
Baltimore, Maryland, United States, 21287
United States, Michigan
Children's Hospital of Michigan - IMPAACT Site
Detroit, Michigan, United States, 48201
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center
Manhattan, New York, United States, 10128
United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Children's Research Center
Memphis, Tennessee, United States, 38105
St. Jude Children's Research Hospital - IMPAACT Site
Memphis, Tennessee, United States, 38105
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Investigators
Study Chair: Sharon Nichols Adolescent Trials Network
  More Information

No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00683579     History of Changes
Other Study ID Numbers: ATN 071
Study First Received: May 21, 2008
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HAART
DHHS guidelines
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014