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Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)

2021年7月30日更新者：AIDS Clinical Trials Group

Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy

The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes the level of HIV in the participants' blood; and how sirolimus interacts with ART in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus had also been used for the prevention of complications after stem cell transplants and as a treatment for certain kinds of cancers in HIV-infected patients.

研究概览

地位

完全的

条件

HIV-1 感染

干预/治疗

药品：Sirolimus

详细说明

The study was conducted with an initial lead-in period of 12 weeks where participants remained on ART, without study intervention. Samples were collected to define the pre-intervention steady-state of HIV, inflammation and immune activation parameters.

At week 12, sirolimus therapy was initiated for the planned 20 weeks of treatment. In order to achieve therapeutic levels, sirolimus therapy was initiated with lead-in dose of 0.025 or 0.05 mg/kg/day, depending on the ART regimen. Doses for each participant were then adjusted, based on trough blood sirolimus concentrations, to achieve target concentrations between 5 and 10 ng/mL. There were frequent initial visits for sirolimus trough concentration monitoring and potential dose adjustments, at weeks 12.5, 13, 13.5, 14, 14.5, 15, 15.5 and 16. Then visits occurred at weeks 18, 20, 24, 28 and 32. After the week 32 visit, the planned end of study treatment, there was an additional 12 weeks of post-sirolimus follow-up, with a final visit at week 44.

Study visits included physical examinations, clinical assessments, safety monitoring, and blood and oral swab collection. Anal swabs were collected at week 12 and 32. Samples were stored for subsequent protocol testing for the study outcomes.

In the primary analysis, the significance level was 0.05 for all analyses.

研究类型

介入性

注册 (实际的)

阶段

阶段2
阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- California
  - San Francisco、California、美国、94110
    - 801 University of California, San Francisco HIV/AIDS CRS
- District of Columbia
  - Washington、District of Columbia、美国、20005
    - Whitman Walker Health CRS (31791)
- Florida
  - Miami、Florida、美国、33136
    - Univ. of Miami AIDS CRS (901)
- Georgia
  - Atlanta、Georgia、美国、30308
    - The Ponce de Leon Center CRS (5802)
- Missouri
  - Saint Louis、Missouri、美国、63110
    - Washington University CRS (2101)
- New York
  - New York、New York、美国、10011
    - Weill Cornell Uptown CRS (7803)
  - Rochester、New York、美国、14642
    - 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS
- Ohio
  - Cincinnati、Ohio、美国、45267
    - Univ. of Cincinnati CRS (2401)
- Texas
  - Houston、Texas、美国、77030
    - Houston AIDS Research Team CRS (31473)
- Washington
  - Seattle、Washington、美国、98104
    - University of Washington AIDS CRS (1401)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

HIV-1 infection
On continuous ART for ≥24 months prior to study entry.
CD4+ cell count ≥350 cells/mm^3
Plasma HIV-1 RNA below the level of quantification for ≥24 months.
White blood cell (WBC) ≥3000/mm^3
Platelet count ≥125,000/mm^3
Absolute neutrophil count (ANC) >1300/mm^3
Aspartate aminotransferase (AST) <1.25 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) <1.25 x ULN
Calculated creatinine clearance (CrCl) ≥60 mL/min
Fasting or non-fasting triglyceride level ≤350 mg/dL
Fasting or non-fasting LDL <160 mg/dL
Urine protein to urine creatinine ratio ≤1 g/g from random urine collection

Exclusion Criteria:

Serious illness requiring systemic treatment and/or hospitalization
Documentation of any CDC Category C AIDS-indicator condition or oropharyngeal candidiasis (thrush)
Intended modification of ART during the study.
Latent tuberculosis (TB) infection
TB disease within 48 weeks prior to study entry requiring treatment.
History of active hepatitis B (HBV) infection.
Hepatitis C virus (HCV) RNA-positive
Previous myelodysplasia syndrome, lymphoproliferative disease, lung disease, malignancies, congestive heart failure, life-threatening fungal infection or herpes-zoster/varicella-zoster viral infection requiring treatment.
Detectable Epstein-Barr virus (EBV) in blood
Active infection other than HIV that required receipt of systemic antibiotic therapy by intravenous infusion
History of major hypersensitivity reaction to macrolide drugs including angioedema, anaphylaxis, drug-induced dermatitis, or hypersensitivity vasculitis.
Currently pregnant or breastfeeding, or planning to become pregnant prior to or during the study.
Use of immunomodulators (eg, interleukins, interferons, and cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy.
Active drug or alcohol use or dependence
Vaccination within 14 days prior to study entry.
On or planned to change to a PI-based ART or cobicistat-boosted regimen
Anti-human papillomavirus (HPV) therapies

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：西罗莫司	药品：Sirolimus Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks. Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Number of Participants Who Met the Study-defined Composite Safety Endpoint 大体时间：Screening to study week 32 (week 20 of Sirolimus)	The study-defined primary safety endpoint was a composite endpoint. A participant was considered to have met the endpoint if the participant 1) experienced a new Grade ≥3 Adverse Event (AE), including signs/symptoms, lab toxicity or clinical event, that was definitely, probably or possibly related to study treatment, as judged by the core team, or 2) had a change in CD4+ cell count ( confirmed >50% decline or to <300 cells/mm3) while on sirolimus. The screening visit occurred within 60 days of study entry.	Screening to study week 32 (week 20 of Sirolimus)
Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Frequency of HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	CD4+ T-cell-associated HIV-1 RNA. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in CD4+ T-cell-associated HIV-1 RNA (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Plasma HIV-1 RNA by SCA 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Plasma HIV-1 RNA by SCA	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in plasma HIV-1 RNA by SCA (week 32 measurement minus baseline measurement). Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)

次要结果测量

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AIDS Clinical Trials Group

合作者

National Institute of Allergy and Infectious Diseases (NIAID)

调查人员

学习椅：Timothy Henrich, MD、University of California, San Francisco
学习椅：Priscilla Hsue, MD、University of California, San Francisco

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年12月21日

初级完成 (实际的)

2017年11月2日

研究完成 (实际的)

2018年2月1日

研究注册日期

首次提交

2015年4月6日

首先提交符合 QC 标准的

2015年5月8日

首次发布 (估计)

2015年5月12日

研究记录更新

最后更新发布 (实际的)

2021年8月3日

上次提交的符合 QC 标准的更新

2021年7月30日

最后验证

2019年12月1日

HIV-1 感染的临床试验

ANRS, Emerging Infectious Diseases
Institut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者

完全的

使用响应性干预预防 HIV-1 的母婴传播 (PROMISE-EPI)

HIV-1

布基纳法索, 赞比亚
Hospital Universitari Vall d'Hebron Research Institute
Gilead Sciences

完全的

与继续使用 Atripla 相比，将 Atripla 改为 Eviplera 的 HIV1 患者血浆脂质谱的演变

HIV-1

西班牙
Hospital Universitari Vall d'Hebron Research Institute
University Hospital, Ghent; IrsiCaixa

完全的

在 PI 和 2 NRTI 基于方案的患者中转换为 Dolutegravir 后的 HIV 库动力学

HIV-1

西班牙
Gilead Sciences

完全的

将齐多夫定和拉米夫定换成特鲁瓦达后的外周体脂肪分布 (RECOMB)

HIV-1

西班牙
University of Aarhus
Aarhus University Hospital Skejby; Bandim Health Project; Abbott; Ministry of Health, Guinea-Bissau

完全的

PI or NNRTI as First-line Treatment of HIV in West Africa - the PIONA Trial (PIONA)

HIV-1

几内亚比绍
Tibotec Pharmaceuticals, Ireland

完全的

TMC125-TiDP35-C213：依曲韦林 (TMC125) 在接受过治疗的 HIV 感染儿童和青少年中的安全性和抗病毒活性

HIV-1

美国, 法国, 西班牙, 葡萄牙, 加拿大, 英国, 南非, 阿根廷, 巴西, 波多黎各, 泰国, 荷兰, 罗马尼亚
Tibotec Pharmaceuticals, Ireland

完全的

在 DUET 试验（TMC125-C206 或 TMC125-C216）中病毒学失败的患者中使用 TMC125 进行的开放标签试验。

HIV-1

美国, 加拿大, 法国, 比利时, 德国, 西班牙, 阿根廷, 智利, 巴拿马, 巴西, 波多黎各, 泰国, 墨西哥, 澳大利亚
Mymetics Corporation
Institut Cochin; San Raffaele University Hospital, Italy; Kinesis Pharma B.V.; CEVAC; M.A.R.C.O.; Mouton... 和其他合作者

完全的

对健康女性受试者肌肉注射和鼻内注射 HIV-1 疫苗的安全性调查

HIV-1

比利时
Pfizer

终止

UK-453,061 与 Etravirine 联合达芦那韦/利托那韦和 Nucleos(t)ide 逆转录酶抑制剂治疗抗逆转录病毒经历过 HIV-1 感染且有 NNRTI 耐药 HIV-1 证据的受试者的 2B 期多中心、随机、比较试验

HIV-1

西班牙, 英国, 马来西亚, 美国, 葡萄牙, 巴西, 德国, 意大利, 波兰, 波多黎各, 南非, 台湾, 乌克兰
University of Oxford
Medical Research Council

终止

Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART

HIV-1

英国

结果测量	措施说明	大体时间
Measurement of CD4+ T-cell Counts 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	CD4+ T-cell counts. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in CD4+ T-cell Counts 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 RNA Levels 大体时间：weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44	HIV-1 RNA levels by conventional assay	weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44
Cell-associated HIV-1 DNA Levels in Total CD4+ Cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	HIV-1 DNA levels in CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in HIV-1 DNA levels in CD4+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells (week 32 measurement minus baseline measurement).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells (week 32 measurement minus baseline measurement).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells (week 32 measurement minus baseline measurement).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %CD69+ CD4+ T-cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Measurement of %CD69+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %CD69+ CD4+ T-cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %CD69+ CD8+ T-cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Measurement of %CD69+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %CD69+ CD8+ T-cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %Ki67+ CD4+ T-cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Measurement of %Ki67+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %Ki67+ CD4+ T-cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement).	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %Ki67+ CD8+ T-cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Measurement of %Ki67+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %Ki67+ CD8+ T-cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %PD1+ CD4+ T-cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Measurement of %PD1+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %PD1+ CD4+ T-cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)
Measurement of %PD1+ CD8+ T-cells 大体时间：At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44	Measurement of %PD1+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).	At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44
Change in of %PD1+ CD8+ T-cells 大体时间：At study weeks 0, 12 and 32 (week 20 on Sirolimus)	Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement)	At study weeks 0, 12 and 32 (week 20 on Sirolimus)

Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy (ART)