EUCTR2009-018001-51-BE进行中（未招募）1 期
A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults. - GSK1349572 vs raltegravir
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 719
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
- •1. ART-experienced, HIV-1 infected subjects >18 years of age.
- •2.A female subject is eligible to enter and participate in the study if she:
- •a.is of non-childbearing 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 Screen and Day 1 and agrees to 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 may be administered with GSK1349572 (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).
- •Any other method with published data showing that the expected failure rate is <1% per year.
- •Any contraception method must be used consistently and in accordance with the approved product label.
- •All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
- •3.HIV-1 infection as documented by HIV-1 RNA >400 c/mL at Screening and with at least one consecutive HIV-1 RNA >400 c/mL within the four months prior to Screening (unless the Screening HIV-1 RNA is > 1000 c/mL where no additional plasma HIV-1 RNA assessment is needed). (If an additional HIV-1 RNA within four months prior to Screening is not available, a second HIV-1 RNA must be performed during the Screening period [after the first result is available] to serve as a confirmatory sample.)
- •4. Has documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents; genotypic resistance is defined by current [IAS, 2009] primary mutations and Monogram genotypic results; phenotypic resistance is defined as values greater than lower cut off for agents where available and by a clinical/biological cut off if an upper cut off is not available; entry resistance is defined by an assay which identifies any CXCR4-utilizing virus, e.g. Trofile; T20 resistance is defined as IC50 > susceptibility cutoff in PhenoSense entry assay. If Screening resistance results provide a fully active agent and do not show two class resistance, then historical resistance results from the subject’s most recent resistance testing may be used for subjects off ART for at least 1 month, after consultation with the study virologist and/or medical monitor.
- •Historic genotypic resistance will be based on IAS Dec 2009 primary mutations guidance or Monogram genotypic results;
- •Historic phenotypic resistance will be accepted only in the absence of corresponding genotypic resistance data, and will be determined based on cutoff criteria from specified platforms as detailed in the SPM;
- •Resistance data must be from within 4 years prior to Study initiation unless it is from a platform listed in the SPM;
- •Further historic resistance guidance will be provided in the SPM. Historical resistance tests along with curren
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •Exclusionary medical conditions
- •1.Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen. For RT and PRO inhibition, fully active is defined by full phenotypic susceptibility (fold change [FC] in 50% inhibitory concentration (IC50) < lower clinical cutoff). Clinical/biological cut off’s should be used to assess activity if upper and lower cut off’s are unavailable for an agent. Entry inhibitor activity is defined by the assay which identifies a viral population as fully CCR5-tropic (e.g., CXCR4-utilizing virus not detected); T20 activity is defined as IC50 < susceptibility cut off in PhenoSense Entry assay.
- •2. Subject-virus does not yield results using genotype/phenotype/tropism at Screening (assay data is essential for eligibility determination.
- •3.Women who are breastfeeding.
- •4.Any evidence of an active Center for Disease and Prevention Control (CDC) Category C disease [CDC, 1993], except cutaneous Kaposi’s sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
- •5.Subjects with moderate to severe hepatic impairment as defined by Child-Pugh classification (see Appendix 11.1).
- •6.Recent history (<3 months) of upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
- •7.Anticipated need for HCV therapy during the study.
- •8.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
- •9.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 study medical monitor for inclusion of the subject.
- •Exclusionary Treatments prior to Screening or Day 1
- •10.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening.
- •11.Treatment with any of the following agents within 28 days of Screening:
- •radiation therapy,
- •cytotoxic chemotherapeutic agents,
- •any immunomodulator.
- •12.Treatment with any agent, other than licensed ART, which has documented activity against HIV-1 in vitro within 28 days of first dose of IP administration.
- •13.Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the experimental test agent - whichever is longer, prior to the first dose of IP.
- •14.French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational drug and/or vaccine within 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 plans to participate simultaneously in another clinical study.
- •Exclusionary Lab Values or Clinical Assessments at Screening
- •15.Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period to verify a Grade 4 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.
- •16.Alanine aminotransferase (ALT) >5 times the upper limit of no
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