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: October 8, 2013
Last verified: August 2013

May 21, 2008
October 8, 2013
December 2007
June 2013   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00683579 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Neurocognitive Assessment in Youth Initiating HAART
Neurocognitive Assessment in Youth Initiating HAART

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
HIV Infections
  • Drug: Early Treatment with HAART
    HAART with possibility of de-intensification
  • 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.
  • 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
  • 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).
    Intervention: 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.
    Intervention: Other: No treatment
  • 3
    Participants with CD4+ T cells < 350 cells/mm3 who are initiating treatment.
    Intervention: Drug: HAART Treatment - standard care
  • 4
    Participants with CD4+ T cells < 350 cells/mm3 who are not initiating treatment.
    Intervention: Other: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00683579
ATN 071
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Sharon Nichols Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP