EUCTR2009-010269-21-IT进行中（未招募）不适用
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. - ND
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 200 人开始时间: 2009年5月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 males or females of non-childbearing potential ≥18 years of age.For the purposes of this trial, a woman is considered of non-childbearing potential if she is physiologically incapable of becoming pregnant.This includes pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy or post-menopausal women (defined as 12 months of spontaneous amenorrhea) 2.HIV-1 infection with a screening plasma HIV-1 RNA ≥1000 c/mL 3. CD4+ cell count ≥100 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 genotypic or phenotypic viral resistance to any antiretroviral drug indicative of primary transmitted resistance in screening genotype or phenotype 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
- •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 of childbearing potential, pregnant women or women who are 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.Subject has estimated creatinine clearance<50 mL/min 10. 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 11. Screening ALT ≥3xULN and bilirubin ≥1.5xULN 15. History of cardiovascular risk factors including clinically significant cardiac disease 16. Personal or family history of prolonged QT syndrome 17. Any clinically significant finding on screening or baseline ECG18. Significant blood loss within a 56day period 19.Immunization within 30 days
研究者
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