EUCTR2010-020983-39-IT进行中（未招募）不适用
A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy na?ve adult subjects. - SINGLE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on GSK1349572 that may impact subject eligibility is provided in the current IB for GSK1349572. Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects are allowed to re-screen for this study one time; this will require a new subject number. A single repeat test (re-test) per analyte or assessment is allowed during the screening period to determine eligibility. The following are study specific eligibility criteria unless stated otherwise. In addition to these criteria, Investigators must exercise clinical discretion regarding selection of appropriate study subjects, taking into consideration any local treatment practices or guidelines and good clinical practice (GCP). 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 GSK . Subjects eligible for enrolment 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). • 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. • Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study (due to potential receipt of blinded efavirenz in this trial). Any contraception method must be used consistently and in accordance with the approved product label. 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-naive
排除标准
- •Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. A single repeat test (re-test) per analyte is allowed during the screening period. Subjects meeting any of the following criteria must not be enrolled in the study: Exclusionary medical conditions 1. Women who are 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. Historical or current CD4 cell counts less than 200cells/mm3 are not exclusionary; 3. Subjects with any degree of hepatic impairment; 4. Positive for Hepatitis B at screening (+HbsAg), or anticipated need for HCV therapy during the study 5. Recent history (?3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding. 6. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class; 7. 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 8. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening; 9. Treatment with any of the following agents within 28 days of Screening i. radiation therapy ii. cytotoxic chemotherapeutic agents iii. any immunomodulator 10. 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 investigational product (IP). Allowed ART cannot be given within 28 days of first dose; 11. 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; 12. 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 if the subject will participate simultaneously in another clinical study; Exclusionary Laboratory or Clinical Assessments at Screening 13. Any evidence of primary viral resistance in the Screening result or, if known, any historical resistance test result; Note: retests of Screening genotypes are not allowed. 14. Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period); 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. 15. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN); 16. ALT ? 3xULN and bilirubin ? 1.5xULN (with >35% direct bilirubin); 17. Subject has creatinine clearance of <50mL/min via Cockroft-Gault method;
研究者
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