2023-505167-36-00已完成3 期
An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease -The Late Presenter Treatment Optimisation Study (LAPTOP)-
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 39
- 主要终点
- Time to failure, as the first occurrence of specified virological or clinical reasons.
研究概览
简要总结
To demonstrate an Integrase Inhibitor containing regimen is no better than a boosted Protease Inhibitor regimen in patients with advanced HIV infection. If the integrase inhibitor regimen is proved to be no better then, we would like to demonstrate whether the Integrase inhibitor regime is superior to the Protease Inhibitor containing regimen.
研究设计
- 分配方式
- Randomized
- 主要目的
- Study duration
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements
- •HIV-1 infected AIDS except active tuberculosis (TB) or cryptococcal meningitis with any CD4 cell count, or; severe bacterial infection (BI) and must have a CD4 cell count < 200/μL within 28 days prior to study entry, or; any symptoms or no symptoms with CD4 cell count < 100/μL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL, or; currently being treated for opportunistic infections (OI)
- •Have an entry HIV viral load > 1000 copies/mL
- •Able to take oral medications
- •ART-naïve prior to study enrolment
- •Willing to use acceptable methods of contraception
排除标准
- •Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours
- •Any investigational drug within 30 days prior to the study drug administration.
- •Patients with severe (Child Pugh class C) hepatic impairment.
- •Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
- •Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi’s sarcoma) or lymphoma.
- •Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).
- •Known resistance to the components of study medications
- •History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR <30 mL/min; hepatic transaminases (AST and ALT) > 5 x upper limit of normal (ULN); or, platelet count <50,
- •Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
- •Cryptococcal meningitis or active TB, or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit).
- •History or presence of allergy to the study drugs or their components, or drugs of their class.
- •Using any concomitant therapy disallowed as per the product labelling for the study drugs.
结局指标
主要结局
Time to failure, as the first occurrence of specified virological or clinical reasons.
Time to failure, as the first occurrence of specified virological or clinical reasons.
次要结局
- Proportion of patients with HIV-RNA viral load < 50 copies/mL at week 24, 36, 48
- HIV-1 drug resistance at confirmed virological failure (genotype)
- Time to reach CD4 count > 200/μL (first measurement)
- Proportion of patients with CD4 cell count < 200 μL and < 350μL at week 4, 8, 12, 24, 36, 48
- CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48
- Incidence of IRIS in the two arms through week 48
- Incidence and duration of hospitalisation, rate of relapse of specific OI/BI through week 48
- Safety and tolerability, measured by Grade 2, 3 and 4 signs and symptoms and laboratory toxicities through week 48
- ART and OI/BI treatment changes and dose modifications due to toxicities and DDI with ART, and IRIS through week 48
- Health care resource use, including total inpatient days and emergency room visits through week 48
- QOL and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at week 48
- Discontinuation or modification of study medication due to insufficient virological response, resistance mutations at baseline, or resistance mutation development before week 48
研究者
Project Manager
Scientific
NEAT ID Foundation
研究点 (39)
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