PER-030-16已完成未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 22
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
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 until the last dose of study medication and completion of the Follow-up visit.
- •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 protocol.
排除标准
- •1.Women who are breastfeeding or plan to become pregnant or breastfeed during the study;
- •2.Any evidence of an active Center s 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/mm.
- •3.Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (Appendix 2, Section 12.2);
- •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:
- •a.Subjects positive for HBsAg are excluded;
- •b.Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) 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 period;
- •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 Screening;
- •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 treatment.
- •15.Any evidence of pre-existing viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2014] in the Screening result or, if known, in any historical resistance test result. NOTE: retests of disqualifying Screening genotypes are not allowed.
- •16.Any verified Grade 4 laboratory abnormality. A singl
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