Treatment De-Intensification and Residual HIV-1 in Adolescents and Young Adults: A Sub-Study of ATN 061 and ATN 071.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 17
- 主要终点
- Steady-state frequencies of replication-competent CD4+ T cell HIV-1 reservoirs in participants starting HAART before DHHS guidelines (CD4+ T cell levels < 350 cells/mm3) vs. those initiating HAART by current DHHS guidelines.
研究概览
简要总结
This laboratory-based sub-study of ATN 061 and ATN 071 will examine the effect of early treatment followed by treatment de-intensification to atazanavir/ritonavir (ATV/r) monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent low-level viremia (LLV), and their contribution to successful long-term control of HIV-1 replication among HIV-1 infected adolescents and young adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •061 Participants
- •Currently on treatment with an ATV/r-based HAART regimen (ATV/r, FTC, TDF is the preferred regimen);
- •HIV-1 viral load < 100 copies at week 24;
- •CD4+ T cell count > 350 cells/mm3 at week 24; and
- •Able to provide informed consent for the sub-study and adhere to the protocol.
- •071 Participants
- •Initiated HAART according to current DHHS guidelines (CD4+ T cells < 350 cells/ mm3);
- •Currently on treatment with a PI-containing HAART regimen; subjects taking a protease inhibitor OTHER than ATV/r must receive approval by the team via the ATN QNS;
- •Plasma HIV-1 viral load < 100 copies at week 24 on HAART; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy;
- •CD4+ T cell count > 350 cells/mm3 at week 24 on HAART; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy; and
- •Able to provide informed consent for the sub-study and adhere to the protocol.
排除标准
- •Currently enrolled in the Standard Care Arm of ATN 061;
- •Pregnancy or breast feeding;
- •Severe (Grade ≥ 3) anemia or other conditions that would not allow adequate blood volume to be drawn;
- •Active treatment for systemic infections;
- •Treatment with immune modulators, including immunosuppressive or immune modulating therapy (IL-2, intravenous gammaglobulin, and therapeutic or other experimental vaccines including HIV-1 vaccine given for primary prevention at any time (short courses (<14 days) of prednisone for reactive airway disease (RAD) are permitted);
- •Active hepatitis B infection as defined by Hepatitis B antigen (Ag) positive;
- •Disallowed Medications (see Section 5.3.2);
- •Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study; or
- •History of chronic renal insufficiency or Grade 3 or greater serum creatinine.
- •061-Specific Exclusion Criteria
- •History of an Acquired Immunodeficiency Syndrome (AIDS)-defining illness;
- •Meets any ATN 061 exclusion criteria for de-intensification; or
- •Meets any ATN 061 premature study discontinuation criteria.
- •071-Specific Exclusion Criteria: None
结局指标
主要结局
Steady-state frequencies of replication-competent CD4+ T cell HIV-1 reservoirs in participants starting HAART before DHHS guidelines (CD4+ T cell levels < 350 cells/mm3) vs. those initiating HAART by current DHHS guidelines.
时间窗: 80 weeks
Quantitative changes in LLV between 6.5 and 50 copies/ml in participants starting early therapy & de-intensifying to ATV/r monotherapy vs. those initiating HAART at CD4+ T cell levels < 350 cells/mm3 & maintaining standard HAART.
时间窗: 80 weeks
Quantitative changes in viral diversity during HAART in participants initiating early therapy & de-intensifying to ATV/r monotherapy vs those initiating HAART at CD4+ T cell levels < 350 cells/mm3 & maintaining standard HAART.
时间窗: 80 weeks
Effect of viral diversity in replication-competent CD4+ T cell reservoirs & low viremia variants before de-intensification on successful control of HIV-1 replication during ATV/r maintenance in participants starting HAART before DHHS guidelines.
时间窗: 80 weeks
次要结局
- To examine the contribution of LLV genotypes, through analysis of the Gag/protease and RT, among subjects who developed rebound viremia above 50 copies/ml during treatment de-intensification to ATV/r.(80 weeks)