EUCTR2011-003629-86-ES进行中（未招募）1 期
A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects. - Dolutegravir vs. darunavir / ritonavir
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 468
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Eligible subjects must:
- •-be able to understand and comply with protocol requirements, instructions, and restrictions;
- •-be likely to complete the study as planned;
- •-be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease).
- •Laboratory results from the central laboratory services provided by this trial will be used to assess eligibility. If results from central laboratory services (e.g., genotypes results) will delay screening beyond the defined 28 day period, use of local laboratory services may be used only after consultation and agreement with the study medical monitor.
- •Subjects eligible for enrollment in this study must meet all of the following:
- •1.HIV-1 infected adults ?18 years of age;
- •2.A female, may be eligible to enter and participate in the study if she:
- •a. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ? 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- •b. is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
- •-Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
- •-Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
- •-Approved hormonal contraception (see the SPM for a listing of examples of approved hormonal contraception);
- •-Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see the SPM for an example listing of approved IUDs);
- •-Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- •-Any other method with published data showing that the expected failure rate is <1% per year.
- •Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP. In subjects treated with DRV/r, alternative methods of non-hormonal contraception are recommended.
- •All subjects participating in the study should be counselled on the practice of safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
- •3.HIV-1 infection as documented by Screening plasma HIV-1 RNA ? 1000 c/mL;
- •4.Antiretroviral-naïve (? 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection);
- •5.Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening;
- •6.For subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •Note: subjects starting ABC as part of the NRTI backbone must be or have been screened and be negative for the HLA-B*5701 allele.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 448
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •Exclusionary medical conditions
- •1.Women who are pregnant or breastfeeding;
- •2.Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease [CDC, 1992], except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell levels <200cells/mm3;
- •3.Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification (see Section 11.1 of protocol);
- •4.Anticipated need for Hepatitis C virus (HCV) therapy during the study;
- •5.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class;
- •6.History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject;
- •Exclusionary Treatments prior to Screening or Day 1
- •7.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;
- •8.Treatment with any of the following agents within 28 days of Screening:
- •- radiation therapy;
- •- cytotoxic chemotherapeutic agents;
- •- any immunomodulators;
- •9.Treatment with any agent, except recognized ART as allowed above (Section 4.2), with documented activity against HIV-1 in vitro within 28 days of first dose of IP;
- •10.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 IP;
- •11.French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational agent during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study;
- •Exclusionary Laboratory Values or Clinical Assessments at Screening
- •12.Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation [IAS-USA, 2010] in the Screening result or, if known, any historical resistance test result. Note: retests of Screening genotypes are not allowed;
- •13.Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period to verify a result). Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject?s participation in the study of an investigational compound is exclusionary;
- •14.Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN);
- •15.ALT ? 3xULN and bilirubin ? 1.5xULN (with 35% direct bilirubin);
- •16.Subject has creatinine clearance of <50 mL/min via Cockroft-Gault method;
- •17.Recent history (? 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
- •Notwithstanding these minimum inclusion and exclusion criteria, Investigators must also follow country specific guidelines where they exist when making decisions about subjects who are eligible for study participation
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