CTIS2023-504993-40-00招募中1 期
A Phase 3b, multi-center, randomized, parallel-group, open-label, non-inferiority study evaluating the efficacy, safety, and tolerability of oral dolutegravir/lamivudine once-daily as a first-line regimen compared to oral bictegravir/emtricitabine/tenofovir alafenamide once daily for virologic suppression and maintenance in antiretroviral therapy naive adults living with HIV - 219816
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •All participants eligible for enrolment in the study must meet all of the following criteria: - Age =18 years (or older, if required by local regulations) at the time of obtaining informed consent. - Male or female. Female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrolment) and not lactating. - Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) person living with HIV. - Participant (or participant’s Legally Acceptable Representative) is capable of giving written informed consent. - Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
排除标准
- •A participant will not be eligible for inclusion in this study if any of the following criteria apply: 1.Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study. 2.Active CDC Stage 3 disease is excluded, except for cutaneous Kaposi's sarcoma not needing systemic therapy, and CD4 cell counts below 200 cells/mm3. 3.Previous or current allergy or intolerance to the study treatment, its components, drugs of their class, or other allergies that contraindicate participation. 4.Ongoing or clinically relevant pancreatitis. 5.Ongoing malignancy, except for specific cases agreed upon by the Investigator and Medical Monitor., 6.Severe hepatic impairment (Class C) as per Child-Pugh classification. 7.Unstable liver disease or known biliary abnormalities (excluding Gilbert's syndrome, asymptomatic gallstones or stable chronic liver disease). 8.History of liver cirrhosis with or without hepatitis viral co-infection. 9.Alanine aminotransferase (ALT) levels =5 times the upper limit of normal (ULN) or ALT =3xULN with bilirubin =1.5xULN (with >35% direct bilirubin) 10.High risk of seizures, unless the risk is deemed low by the Investigator., 11.Significant suicidality risk, based on investigator judgment or history of suicidal behavior or ideation. 12.Signs and symptoms suggestive of active SARS-CoV-2 infection within 14 days before enrolment. 13.Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening, unless immune. 14.Participants with HCV co-infection are eligible if: liver enzymes meet entry criteria; there is no anticipated requirement for concomitant HCV treatment with potential adverse drug interactions, and HCV disease has undergone appropriate work-up and is not advanced or associated with cirrhosis. 15.Untreated syphilis infection (positive RPR at Screening). Participants =7 days post completed treatment are eligible., 16.Major resistance-associated mutations to specified drugs based on resistance guidelines. 17.Recent exposure to experimental drugs or vaccines, meeting protocol-defined conditions, before first dose of study drug. 18.Treatment with radiation therapy, cytotoxic chemotherapeutic agents, or systemic immune suppressants within 28 days of screening. 19.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. 20.Treatment with agents active against HIV-1, except recognized antiretroviral therapy (ART), within 28days of first study dose., 21.Participants receiving protocol-defined prohibited medications who are unwilling or unable to switch to alternate medication 22.Grade 4 laboratory abnormalities, excluding lipid abnormalities. 23.Acute laboratory abnormalities at Screening that, per investigator judgement, preclude participation in a clinical trial. 24.Estimated creatine clearance below 30 mL/min per 1.73 m2 using the refitted, race-neutral CKD-EPIcr_R method 25.Known or suspected acquisition of HIV-1 during either pre-exposure prophylaxis or post-exposure prophylaxis use, requiring consultation with Medical Monitor before enrolment., 26.Conditions affecting drug absorption, distribution, metabolism, or excretion. 27.Pre-existing conditions that may interfere with dosing, protocol compliance, or participant safety. 28.Current or expected participation in another interventional study after randomization, unless pre- approved by the medical monitor
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