NL-OMON50555已完成3 期
A Phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naïve adults - GSK ViiV 204861 / Gemini 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
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 99（—）
入选标准
- •1. HIV-1 infected adults >=18 years of age (or older, if required by local
- •regulations), at the time of signing the informed consent.
- •2. Screening plasma HIV-1 RNA of 1000 c/mL to <=100,000 c/mL. If an independent
- •review of accumulated data from other clinical trials investigating the DTG
- •plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen,
- •enrolment will be opened to subjects with Screening plasma HIV-1 RNA of 1000
- •c/mL to <=500,000 c/mL;
- •3. Antiretroviral-naïve (defined as <=10 days of prior therapy with any
- •antiretroviral agent following a diagnosis of HIV-1 infection). Subjects who
- •received HIV postexposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP)
- •in the past are allowed as long as the last PEP/PrEP dose was >1 year from HIV
- •diagnosis or there is documented HIV seronegativity between the last
- •prophylactic dose and the date of HIV diagnosis.
- •4.Male or female.
- •A female subject is eligible to participate if she is not pregnant as
- •confirmed by a negative serum human chorionic gonadotrophin (hCG)
- •test at Screening and negative urine test at Baseline), not lactating, and
- •at least one of the following conditions applies:
- •a.Non-reproductive potential defined as:
- •Pre-menopausal females with one of the following:
- •Documented tubal ligation
- •Documented hysteroscopic tubal occlusion procedure with follow-up
- •confirmation of bilateral tubal occlusion
- •Hysterectomy
- •Documented Bilateral Oophorectomy
- •Postmenopausal defined as 12 months of spontaneous amenorrhea and
- •>=45 years of age [in questionable cases a blood sample with
- •simultaneous follicle stimulating hormone (FSH) and oestradiol levels
- •consistent with menopause is confirmatory (refer to laboratory
- •reference ranges for confirmatory levels)]. Females on hormone
- •replacement therapy (HRT) and whose menopausal status is in doubt
- •will be required to use one of the highly effective contraception methods
- •if they wish to continue their HRT during the study. Otherwise, they
- •must discontinue HRT to allow confirmation of post-menopausal status
- •prior to study enrolment.
- •b.Reproductive potential and agrees to follow one of the options listed in
- •the Modified List of Highly Effective Methods for Avoiding Pregnancy in
- •Females of Reproductive Potential (FRP) (see Appendix 9, Section
- •12.9.1) from 30 days prior to the first dose of study medication and for
- •at least 2 weeks after the last dose of study
- •medication.
- •The investigator is responsible for ensuring that subjects understand
- •how to properly use these methods of contraception.
- •All subjects participating in the study should also be counselled on safer
- •sexual practices, including the use and benefit/risk of effective barrier
- •methods (e.g. male condom), and on the risk of HIV transmission to an
- •uninfected partner.
- •5. Subject or the subject*s legal representative capable of giving signed
- •informed consent as described in Section 10.2 which includes compliance with
- •the requirements and restrictions listed in the consent form and in this
排除标准
- •1. Women who are breastfeeding or plan to become pregnant or breastfeed during
- •2. Any evidence of an active Centers for Disease Control and Prevention (CDC)
- •Stage 3 disease [CDC, 2014], except cutaneous Kaposi*s sarcoma not requiring
- •systemic therapy and historical or current CD4 cell counts less than 200
- •cells/mm3.
- •3. Subjects with severe hepatic impairment (Class C) as determined by
- •Child-Pugh classification;
- •4. Unstable liver disease (as defined by the presence of ascites,
- •encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices,
- •or persistent jaundice), cirrhosis, known biliary abnormalities (with the
- •exception of Gilbert's syndrome or asymptomatic gallstones);
- •5. Evidence of HBV infection based on the results of testing at Screening for
- •HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody
- •(anti-HBs or HBsAb), and HBV DNA as follows:
- •Subjects positive for HBsAg are excluded;
- •Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg
- •and positive for HBV DNA are excluded.
- •NOTE: Subjects positive for anti-HBc (negative HBsAg status) and positive for
- •anti- HBs (past and/or current evidence) are immune to HBV and are not excluded.
- •6. Anticipated need for any HCV therapy during the first 48 weeks of the study
- •and for HCV therapy based on interferon or any drugs that have a potential for
- •adverse drug:drug interactions with study treatment throughout the entire study
- •7. Untreated syphilis infection (positive rapid plasma reagin [RPR] at
- •Screening without clear documentation of treatment). Subjects who are at least
- •14 days post completed treatment are eligible.
- •8. History or presence of allergy or intolerance to the study drugs or their
- •components or drugs of their class;
- •9. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell
- •carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or
- •cervical, anal or penile intraepithelial neoplasia; other localised
- •malignancies require agreement between the investigator and the Study Medical
- •Monitor for inclusion of the subject.
- •10. Subjects who in the investigator*s judgment, poses a significant
- •suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation
- •may be considered as evidence of serious suicide risk.
- •11. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of
- •12. Treatment with any of the following agents within 28 days of Screening
- •i. radiation therapy,
- •ii. cytotoxic chemotherapeutic agents,
- •iii. any systemic immune suppressant;
- •13. Treatment with any agent, except recognised ART as allowed above (inclusion
- •criterion 3.), with documented activity against HIV-1 in vitro within 28 days
- •of first dose of study treatment;
- •14. Exposure to an experimental drug or experimental vaccine within either 28
- •days, 5 half-lives of the test agent, or twice the duration of the biological
- •effect of the test agent, whichever is longer, prior to the first dose of study
- •15. Subjects enrolled in France (and other countries as required by local
- •regulations or ethics committees/IRBs): the subject has participated in any
- •study using an investigational drug during the previous 60 days or 5
- •half-lives, or twice the duration of the biological effect of
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