Virologic Response at 48 th Week, in Patients Newly Diagnosed With HIV-1, After the Implementation of a Test and Treat Model of Care, in a Single Portuguese Center.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Percentage of Newly Diagnosed Participants with Human Immunodeficiency Virus (HIV)-1 Ribonucleic acid (RNA) < 50 Copies per Milliliter (c/mL) at Week 48 (Virologic Response)
研究概览
简要总结
The purpose of this study is to determine the proportion of newly diagnosed participants with Human Immunodeficiency Virus (HIV)-1 (naive participants) with virologic response at Week 48-defined as HIV-1 Ribonucleic acid (RNA) less than (<) 50 copies/milliliter (mL) (Food And Drug Administration snapshot) - after the implementation of the Test & Treat model of care and in a historical cohort.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective cohort: Newly diagnosed with Human Immunodeficiency Virus (HIV)-1 evidenced by any of the following: or HIV Rapid Antibody positive; HIV Immunoassay positive; positive HIV (p24) antigen; or detectable HIV-1 Ribonucleic acid (RNA) Viral Load and non-reactive antibody/antigen assays. HIV-1 RNA Viral Load must be confirmed within one week of initial HIV-1 RNA Viral Load test
- •Prospective cohort: Antiretroviral (ARV) treatment-naïve who will initiate treatment. Retrospective cohort: Dates of HIV-1 diagnosis and ARV treatment initiation available in clinical records
- •Prospective and Retrospective cohorts: Must sign [and/or their legally-acceptable representative where applicable must sign,] a participation agreement/ Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
排除标准
- •Known Acquired Immune Deficiency Syndrome (AIDS)-defining condition
- •Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Antiretroviral Therapy (ART)
- •Known history of chronic renal insufficiency, defined as having an eGFR less than (<) 50 milliliter/minute (ml/min) according to the Cockcroft-Gault formula
- •Known active severe infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to screening
- •Known history of cirrhosis as diagnosed based on local practices
研究组 & 干预措施
Prospective Cohort
Participants newly diagnosed with Human Immunodeficiency Virus (HIV)-1, will receive Antiretroviral Therapy (ART) in accordance with clinical practice and will be included in a Test and Treat model of care at the outpatient clinic of the center.
干预措施: Antiretroviral Therapy (Drug)
Historical Cohort
Naive HIV-1 infected participants who had their first care visit at the outpatient clinic of the center through 2017 will be included in this cohort.
干预措施: Antiretroviral Therapy (Drug)
结局指标
主要结局
Percentage of Newly Diagnosed Participants with Human Immunodeficiency Virus (HIV)-1 Ribonucleic acid (RNA) < 50 Copies per Milliliter (c/mL) at Week 48 (Virologic Response)
时间窗: Week 48
The percentage of newly diagnosed participants is defined as the percentage of newly HIV-1 infected participants that are considered virologic responders (that is have HIV-1 RNA viral load less than \[\<\] 50 c/mL) at Week 48 as per the Food And Drug Administration (FDA) snapshot algorithm.
次要结局
- Time to Antiretroviral Therapy (ART) Initiation since HIV-1 Diagnosis(Up to 48 weeks)
- Change from Baseline in HIV-1 RNA from Start of ART(Baseline up to week 48)
- Change from Baseline in Cluster Differentiation 4 (CD4) Cell Count(Baseline up to Week 48)
- Percentage of Participants not Lost-to-Follow up(12 months)
- Time to Virologic Suppression(Up to 48 weeks)
- Time to Virologic Response(Up to 48 weeks)
- Change from Baseline in Viral Load(Baseline up to Week 48)
- Time from HIV Diagnosis to First Care Visit(Baseline (Day 1))
- Time from First Care Visit to ART Initiation(Baseline (Day 1))
- Percentage of Participants Developing PR, RT, and INI Resistance-Associated Mutation (RAMs) During Follow-up(Through 4, 6, 12, 24 and 48 weeks)
- Percentage of Participants who Loss-to-Follow According to Burkitt lymphoma (BL) CD4 cell Count(Up to 24 Months (end of study))
- Change from Baseline in ARV Regimen due to Resistance(Baseline up to Week 48)