EUCTR2011-003329-89-HU进行中（未招募）不适用
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose.Revised Protocol 01 to incorporate Protocol Amendment 02
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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
- 300
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) Signed Written Informed Consent:
- •Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study.
- •2) Target Population:
- •a) Men and women at least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher),
- •b) Plasma HIV-1 RNA > 5000 copies/mL,
- •c) Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week of an antiretroviral drug,
- •d) CD4 + T-cell count > 200 cells/mm3.
- •3) Age and Reproductive Status:
- •a) Women of childbearing potential (WOCBP) and men must be using at least 2 acceptable methods of contraception, including at least one barrier method, to
- •avoid pregnancy throughout the study, for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized,
- •b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start
- •of investigational product,
- •c) Women must not be breastfeeding,
- •d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) Target Disease Exceptions:
- •a) History of genotypic and/or phenotypic drug resistance testing showing resistance to EFV, TDF, or 3TC.
- •b) Screening HIV-1 genotypic drug resistance testing showing resistance to EFV, TDF, or 3TC, as defined by the presence of any in the following:
- •EFV RT: A98G, L100I, K101E/Q/R/P, K103N, V106M, V108I, V179D, Y181C/I, Y188L, G190S/A/T, P225H, F227L, M230I/L;
- •TDF RT: M41L, K65R, D67N, K70R/E, T69 insertion, L74V, L210W, Y115F, Q151M, T215Y/F, K219Q/E/N;
- •3TC RT: M184V/I, K65R.
- •c) Screening HIV-1 genotypic drug resistance testing showing primary protease inhibitor resistance mutations as defined by the presence of any of the following:
- •PR: D30N, M46I/L, I47V/A, G48V, I50L, I54M/L, Q58E, T74P, L76V, V82A/F/L/T/S, N83D, I84V, N88S, L90M.
- •2) Medical History and Concurrent Diseases:
- •a) Any gastrointestinal disease or surgical procedure that may impact absorption of study drug,
- •b) Presence of a newly diagnosed HIV-related opportunistic infection (OI) or any medical condition requiring acute therapy at the time of enrollment; suspected primary (acute) HIV infection,
- •c) History of or current presence of clinically relevant cardiac disease, defined by presence of arrhythmias, ischemic disease, or a conduction abnormality including
- •2nd/3rd degree atrioventricular block (AVB), or any cardiac abnormality deemed clinically relevant by investigator,
- •d) Personal or family history of long QT syndrome,
- •e) History of seizures or other clinically relevant CNS disorders,
- •f) History of diagnosed and uncontrolled mental illness,
- •g) History of suicidal ideation or attempt,
- •h) History of Idiopathic Thrombocytopenia Purpura or clinically relevant diagnosis of thrombocytopenia,
- •i) Active alcohol or substance use which in the investigator’s opinion is sufficient,
- •to prevent adequate adherence with study therapy or make participation in the study not in the best interest of the subject.
- •3) Physical and Laboratory Test Findings:
- •a) Liver enzymes (ALT/AST) > 3 times the upper limit of normal,
- •b) Alkaline phosphatase > 5 times the upper limit of normal,
- •c) Creatinine clearance < 60 cc/min,
- •d) Hemoglobin < 8.0 g/dL,
- •e) Platelets < 75,000 cells/mm3,
- •f) Positive blood screen for HBsAg,
- •g) Positive blood screen for HCV Ab and HCV RNA,
- •h) Confirmed QT value > 500 msec at Screening or Day -1,
- •i) Confirmed QTc value > 470 msec for women and > 450 msec for men at Screening or Day -1,
- •j) Confirmed PR Interval > 260 msec (severe first degree AV block),
- •k) Confirmed second or third degree heart block at Screening or Day -1,
- •4) Allergies and Adverse Drug Reaction,
- •a) History of allergy to TDF, EFV, or 3TC,
- •b) History of clinically relevant severe drug reaction (such as anaphylaxis or hepatotoxicity.
- •5) Other Exclusion Criteria:
- •a) Prisoners or subjects who are involuntarily incarcerated
- •b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness,
- •c) Contraindications to any of the study drugs.
研究者
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