EUCTR2007-004225-26-ES进行中（未招募）不适用
Estudio doble ciego, con doble agente ficticio, multicéntrico, aleatorizado en fase 3 de la seguridad y la eficacia de elvitegravir reforzado con ritonavir (EVG/r) en comparación con raltegravir (RAL) cada uno administrado con un régimen de fondo en sujetos adultos infectados por VIH-1 que han recibido tratamiento antirretroviral.A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL)Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.
Gilead Sciences Incorporated0 个研究点目标入组 700 人开始时间: 2008年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
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
- •Exemptions for inclusion and exclusion criteria will not be granted.
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Plasma HIV-1 RNA levels = 1,000 copies/mL at screening using the AmpliPrep/Taqman HIV-1 Test® (with a reflex dilution for results > 10,000,000 copies/mL).
- •Subjects must have documented resistance, as defined by current IAS-USA definitions (refer to Appendix 5 of the protocol), or at least six months experience prior to screening with two or more different classes of antiretroviral agents. Thus, subjects may have resistance to one class and at least six months experience prior to screening with a second class of antiretroviral agents, or resistance to two classes of antiretroviral agents, or at least six months experience with the two classes of antiretroviral agents. Subjects may also have resistance or at least six months experience prior to screening with three or more classes of antiretroviral agents.
- •Stable antiretroviral regimen for at least 30 days prior to screening and must remain on screening regimen until the baseline visit.
- •Subjects must be eligible to receive one of the fully-active ritonavir-boosted-PIs, based on the results of screening phenotype analysis provided by Monogram Biosciences, and an allowed second agent (see Table 3-1). Fully-active PIs are defined as those with fold changes below the lower clinical or biological cutoff for each drug.
- •Normal ECG (or if abnormal, determined by the investigator to be not clinically
- •significant).
- •Adequate renal function:
- •Estimated glomerular filtration rate = 60 mL/min according to the Cockcroft-Gault
- •Male: (140 – age in years) × (wt in kg) = CLcr (mL/min)/ 72 × (serum creatinine in mg/dL)
- •Female: (140 – age in years) × (wt in kg) × 0.85 = CLcr (mL/min)/ 72 × (serum creatinine in mg/dL)
- •Hepatic transaminases (AST and ALT) = 2.5 × upper limit of normal (ULN).
- •Total bilirubin = 1.5 mg/dL, or normal direct bilirubin (subjects with documented
- •Gilbert’s Syndrome or hyperbilirubinemia due to indinavir or atazanavir therapy may
- •have total bilirubin up to 5 × ULN).
- •Adequate hematologic function (absolute neutrophil count = 1,000/mm3; platelets
- •= 50,000/mm3; hemoglobin = 8.5 g/dL).
- •Prothrombin Time = 1.25 × ULN.
- •Serum amylase < 1.5 × ULN (subjects with serum amylase = 1.5 × ULN will remain
- •eligible if serum lipase is = 1.5 × ULN).
- •Negative serum pregnancy test (females of childbearing potential only).
- •Males and females of childbearing potential (i.e., a non-menopausal female or a female with menopausal = 2 years, who has not had a hysterectomy, bilateral oophorectomy or medically documented ovarian failure; this definition includes a young woman who has not yet started menstruating) must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs.
- •- Female subjects who utilize hormonal contraceptive as one of their birth control
- •methods must have used the same method for at least three months prior to study
- •- Female subjects who are postmenopausal for less than two years are required to have FSH > 40 mIU/mL. If the FSH is = 40 mIU/mL, the subject must agree to use highly effective method o
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in (or may be discontinued from) this study:
- •A new AIDS-defining condition diagnosed within the 30 days prior to screening (Refer to Appendix 6 of the protocol)
- •Prior treatment with any HIV-1 integrase inhibitor
- •Subjects experiencing ascites
- •Subjects experiencing encephalopathy
- •Females who are breastfeeding
- •Positive serum pregnancy test at any time during the study (female of childbearing
- •Subjects receiving ongoing therapy with any medication listed in section 4.3. of the protocol that is not to be taken with a component of the BR, including drugs not to be used with ritonavir (refer to prescribing information). Administration of any of the medications detailed in section 4.3. of the protocol must be discontinued at least 30 days prior to the Baseline/Day 1 visit and for the duration of the study.
- •Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
- •Malignancy other than cutaneous Kaposi’s sarcoma (KS) or basal cell carcinoma.
- •Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received
- •any systemic therapy for KS within 30 days of Baseline and are not anticipated to require systemic therapy during the study.
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline.
- •Participation in any other clinical trial (except for the Etravirine expanded access
- •program), without prior approval from the sponsor, is prohibited while participating in
- •this trial.
- •Any other clinical condition or prior therapy that, in the opinion of the investigator,
- •would make the subject unsuitable for the study or unable to comply with the dosing
- •requirements.
- •Known hypersensitivity to the study drugs, the metabolites or formulation excipients.
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