JPRN-jRCT2051230132招募中4 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
Kajiwara Makoto0 个研究点目标入组 412 人开始时间: 2023年11月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 412
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants with age >=18 years (or older, if required by local regulations) at the time of obtaining informed consent.
- •-An individual participant is eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrollment) and not lactating.
- •-Antiretroviral-naive (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 [LAR]) is capable of giving written informed consent.
- •-Eligible participants or their LAR must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
排除标准
- •1. Individuals who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
- •2. Any evidence of a current Centers for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count <200 cells/mm3 (neither is exclusionary).
- •3. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates study participation.
- •4. Ongoing or clinically relevant pancreatitis.
- •5. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the Investigator and the Medical Monitor for inclusion of the participant prior to enrolment.
- •6. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
- •7. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- •8. History of liver cirrhosis with or without hepatitis viral co-infection.
- •9. Alanine aminotransferase (ALT) -5 times the upper limit of normal (ULN) or ALT -3xULN and bilirubin -1.5xULN (with >35% direct bilirubin).
- •10. Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment.
- •11. Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
- •12. Signs and symptoms which, in the opinion of the Investigator, are suggestive of active COVID-19 (e.g., fever, cough) infection within 14 days prior to enrollment.
- •13. Evidence of Hepatitis B virus (HBV) infection based on the results of central lab testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and HBV Deoxyribonucleic Acid (DNA) as follows:
- •-Participants positive for HBsAg are excluded;
- •-Participants negative for HBsAb and negative for HBsAg but positive for HBcAb may be excluded based on the following consideration:
- •i. Exclude if HBV DNA is detected [either < Lower Limit of Quantification (LLoQ), > Upper Limit of Quantification (ULoQ) OR numerical value (ie, between LLoQ and ULoQ)]
- •ii. Not excluded if HBV DNA is negative, not detected
- •14. Participants with HCV co-infection at Screening are eligible only if:
- •i. liver enzymes meet entry criteria; and
- •ii. HCV disease is not anticipated to require on-study treatment with any agent(s) that have potential adverse DDIs with the study interventions; and
- •iii. HCV disease has undergone appropriate work-up and is not advanced and will not require treatment prior to th
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