EUCTR2009-010269-21-DE进行中（未招募）1 期
A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects.
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
- 200
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 adults > 18 years of age. A female is eligible to enter and participate in the study if she falls into one of the following categories:
- •a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy or post-menopausal defined as 24 months of spontaneous amenorrhea; or,
- •b. Child-bearing potential, with a negative pregnancy test at screen and a negative pregnancy test at Day1, who agrees to use one of the methods of contraception listed in the protocol. Premenarchal females who develop child-bearing potential while on study will also be expected to follow one to the methods of contraception listed in the protocol.
- •2.HIV-1 infection with a screening plasma HIV-1 RNA =1000 c/mL
- •3.CD4+ cell count =200 cells/mm3 (or higher as local guidelines dictate)
- •4.ART-naive defined as having <10 days of prior therapy with any antiretroviral agent. Any previous exposure to an HIV integrase inhibitor other than GSK1349572 will be exclusionary.
- •5.Subject has no evidence of viral resistance to any antiretroviral drug indicative of primary transmitted resistance in screening genotype or historical resistance test result
- •6.Able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
- •7.Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening.
- •8. French subjects: 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
- •1.Any pre-existing mental, physical, or substance abuse disorder which may interfere with the subject’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject
- •2.Women who are pregnant or breastfeeding
- •3.Any evidence of an active CDC Category C disease except cutaneous Kaposi’s sarcoma not requiring systemic therapy at the screening visit.
- •4.Previous participation in an experimental drug and/or vaccine trials (s) within 30 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer
- •5.History of ongoing or clinically relevant pancreatitis or hepatitis within the previous 6 months, including chronic HBV infection.
- •6.Serious medical condition which would compromise the safety of the subject
- •7.Any condition which may interfere with the ADME of the drug or render the subject unable to take oral medication.
- •8.Any acute laboratory abnormality at screening, which would preclude the subject’s participation in the study of an investigational compound.
- •9. History of upper gastrointestinal bleed (unless in the opinion of the Investigator and Sponsor the primary cause was reversible and has been adequately treated) and/or subjects with active peptic ulcer disease
- •10.Subject has estimated creatinine clearance <50 mL/min
- •11.ALT =5 times ULN. Subjects with ALT > 2xULN but <5xULN may participate in the study if the abnormality will not interfere with the study procedures or compromise subject safety
- •12.Screening ALT =3xULN and bilirubin =1.5xULN
- •13. Lipase >3xULN
- •14. Hemoglobin <100 g/L(10g/dL)
- •15.History or presence of allergy or intolerance to the study drugs or drugs of their class, or a history of drug or other allergy that contraindicates participation.
- •16.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need during the study
- •17.Required treatment with immunomodulators within 28 days or subject has received an HIV-1 immunotherapeutic vaccine within 90 days
- •18.Treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration
- •19.History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia
- •20.Personal or family history of prolonged QT syndrome
- •21.Any clinically significant finding on screening or baseline ECG
- •22.Significant blood loss within a 56 day period
- •23.Immunization within 30 days
- •24. French subjects: 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 the experimental drug or vaccine – whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study.
研究者
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