NCT03227861已完成3 期
A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
研究概览
简要总结
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (>=) 5,000 copies per milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1 RNA viral load (>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test
- •Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP)
- •Must be able to swallow whole tablets
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug
- •A woman of childbearing potential must have a negative urine pregnancy test at screening
排除标准
- •Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality
- •Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF FDC)
- •Known history of cirrhosis as diagnosed based on local practices
- •Known history of chronic ([>=] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (<) 50 milliliter per minute (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula
- •Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
研究组 & 干预措施
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Experimental
Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.
干预措施: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC (Drug)
结局指标
主要结局
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
时间窗: Week 48
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
次要结局
- Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48(Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48)
- Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit(Up to Week 48)
- Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48(Weeks 4, 8, 12, 24, 36, and 48)
- Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48(Week 24 and 48)
- Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48(Weeks 4, 8, 12, 24, 36, and 48)
- Number of Participants With Emergency Room Visits(Up to Week 48)
- Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])(Up to Week 48)
- Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96(Up to Week 96)
- Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96(Up to Week 96)
- Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)(Baseline (Day 1))
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24(Week 24)
- Number of Participants With Hospitalizations(Up to Week 48)
- Number of Participants With Outpatient Visits(Up to Week 48)
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48(Baseline, Weeks 12, 24 and 48)
- Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules(Up to Week 48)
- Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)(Up to Week 48)
- Percentage of Participants Experiencing Grade 3 and 4 Adverse Events(Up to Week 48)
- Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)(Up to Week 48)
- Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities(Up to Week 48)
- Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings(Up to Day 35)
- Duration of Hospitalizations(Up to Week 48)
- Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment(Up to Week 48)
- Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48(Weeks 4, 24, and 48)
- Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96(Up to Week 96)
- Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96(Weeks 72 and 96)
研究者
研究点 (15)
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