Neurocognitive Assessment in Youth Initiating HAART
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 21
- 主要终点
- The impact of early initiation of HAART on preventing neurocognitive decline in HIV infected adolescents compared to no treatment and initiation following current guidelines.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Early Treatment with HAART (Drug)
2
Participants with CD4+ T cells above 350 cells/mm3 and HIV RNA >1,000 copies/ml who are not initiating treatment.
干预措施: No treatment (Other)
3
Participants with CD4+ T cells < 350 cells/mm3 who are initiating treatment.
干预措施: HAART Treatment - standard care (Drug)
4
Participants with CD4+ T cells < 350 cells/mm3 who are not initiating treatment.
干预措施: No treatment (Other)
结局指标
主要结局
The impact of early initiation of HAART on preventing neurocognitive decline in HIV infected adolescents compared to no treatment and initiation following current guidelines.
时间窗: 3 years
次要结局
- To assess the incidence of HIV-associated dementia and minor cognitive-motor disorder in adolescents with risk-acquired HIV infection.(3 years)
- 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.(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 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)