EUCTR2009-018001-51-NL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. - N/A
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.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] primary mutations; 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. Historical resistance tests should be used to aid in selection of background therapy. Note: retests of Screening genotypes/phenotypes/tropism assays are not allowed.
- •5.Is INI-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).
- •6.Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening.
- •7.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.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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.
- •2.Subject-virus is not evaluable using genotype/phenotype/tropism at Screening (assay data is essential for determination of inclusion and/or background therapy).
- •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 normal (ULN).
- •17.ALT > 3xULN and bilirubin > 1.5xULN (with >35% direct bilirubin).
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