NCT01102972已完成4 期
A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, HIV-1 Infected, HLA-B*5701 Negative Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
研究概览
简要总结
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B*5701 negative subjects for 48 weeks.
详细描述
A prospective, randomized, multicenter, open-label study to compare the efficacy and safety of simplifying from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV for 48 weeks in virologically suppressed, HIV-1 infected, HLA-B*5701 negative subjects.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an adult (greater than or equal to 18 years) with documented HIV-1 infection
- •Subject is a male or female of non-childbearing potential (physiologically incapable of becoming pregnant, is pre-menarchal or post-menopausal) or child-bearing potential with a negative pregnancy test who agrees to avoid pregnancy by sexual abstinence or utilization of a highly effective method of birth control throughout the study period
- •Subject is receiving a once-daily regimen of ATV (300mg) + RTV (100mg) + TDF/FTC (300mg/200mg) for at least 6 months prior to or by the first day of screening. ATV + RTV + TDF/FTC must be the subejct's INITIAL regimen or FIRST or SECOND SWITCH regimen. If ATV + RTV + TDF/FTC is subject's first or second switch regimen, then subject may ONLY have received the following prior regimens: a) any currently licensed non-nucleoside reverse transcriptase inhibitor (NNRTI) + TDF/FTC or ZDV/3TC; b) RTV-boosted PI with TDF/FTC or ZDV/3TC; or c) an alternative regimen not listed above after approval by Sponsor.
- •Subject is virologically suppressed on ATV + RTV + TDF/FTC defined as HIV-1 RNA </=75 copies/mL at 2 consecutive timepoints, one of which is at Screening and the other at least 28 days prior to Screening
排除标准
- •Subject has evidence of virologic failure
- •Subject has any known HIV genotyping results indicating HIV virus contains any of the following resistance mutations in reverse transcriptase including K65R, K70E, L74V, M184I/V or Y115F, a combination of two or more thymidine analog mutations including M41L, D67N, K70R, K219Q or E that include changes at either L210 or T215), or 3 or more of the following HIV-1 protease mutations associated with atazanavir resistance: D30, V32, M36, M46, I47, G48, I50, I54, A71, G73, V77, V82, I84, N88, and L90
- •Subject is HLA-B*5701 positive
- •Subject has hypersensitivity to any component of the study drugs
- •SUbject is pregnant or breastfeeding
- •Subject is enrolled in one or more investigational drug protocols within 30 days of screening
- •Subject has an active Center for Disease Control and Prevention (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial
- •Subject has ongoing clinically relevant hepatitis at screening and/or positive for Hepatitis B (+ HbsAg)
- •Subject has a creatinine clearance <50 mL/min via the Cockcroft-Gault method
- •Subject has a verified Grade 4 laboratory abnormality at screening unless the Investigator can provide a compelling explanation (e.g. elevated CPK due to exercise) for the laboratory result(s) and has the assent of the Sponsor
- •Subject has any other laboratory abnormality or medical condition at screening, which, in the opinion of the investigator, would preclude the subject's participation in the study
- •Subject has had an immunization within 30 days prior to first dose of investigational product
- •Subject has had any exposure to treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, or interferons) or receipt of an HIV-1 immunotherapeutic vaccine within 90 days prior to screening. Subjects using inhaled corticosteroids or short-course systemic corticosteroids (less than or equal to 14 days) are eligible for enrollment.
- •Subject has had treatment with radiation therapy or cytotoxic chemotherapeutic agents within 90 days prior to screening, or has an anticipated need for these agents within the study period
- •Subject has had treatment within 30 days prior to first dose of investigational product for or an anticipated need during the study of any medications which can have interactions with the study medications, TDF, FTC, ABC, 3TC, ATV and/or RTV, as described in current product labelling
- •Subject has had treatment with any previous abacavir-containing regimen
研究组 & 干预措施
ATV + ABC/3TC
Experimental
Subjects will change to ATV 400mg administered as two 200mg capsules orally, once daily and to the fixed-dose combination tablet of ABC 600mg/3TC 300mg (EPZICOM) administered as one tablet orally, once daily for 48 weeks. The subject's pre-study RTV will be discontinued.
干预措施: Reyataz + Epzicom (Drug)
ATV + RTV + TDF/FTC
Active Comparator
Subjects will continue their pre-study therapy, un-modified, of ATV 300mg administered as one capsule orally, once daily plus RTV 100mg administered orally, once daily plus fixed dose combination tablet tenofovir 300mg/emtricitabine 200mg administered as one tablet orally, once daily for 48 weeks.
干预措施: Reyataz + Norvir + Truvada (Drug)
结局指标
主要结局
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
时间窗: Week 24
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.
次要结局
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses(Week 24)
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses(Week 48)
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis(Week 24)
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis(Week 48)
- Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24(From Baseline to Week 24)
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses(Week 24)
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses(Week 48)
- Change From Baseline in HIV-1 RNA at Week 24(Baseline and Week 24)
- Change From Baseline in CD4+ Cell Count at Week 24(Baseline and Week 24)
- Change From Baseline in Cholesterol/HDL Ratio at Week 48(Baseline and Week 48)
- Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48(From Baseline to Week 48)
- Number of Participants Who Experienced Death and/or Disease Progression(From Baseline to Week 48)
- Change From Baseline in HIV-1 RNA at Week 48(Baseline and Week 48)
- Change From Baseline in CD4+ Cell Count at Week 48(Baseline and Week 48)
- Change From Baseline in Cholesterol/HDL Ratio at Week 24(Baseline and Week 24)
- Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24(Baseline and Week 24)
- Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48(Baseline and Week 48)
- Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24(From Baseline to Week 24)
- Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48(From Baseline to Week 48)
- Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir(From Baseline to Week 24)
- Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir(From Baseline to Week 48)
- Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group(From Baseline to Week 48)
研究者
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