A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
2015年9月24日 更新者：Bristol-Myers Squibb
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
調査の概要
研究の種類
介入
入学 (実際)
238
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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California
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Beverly Hills、California、アメリカ、90211
- Pacific Oaks Medical Group
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Long Beach、California、アメリカ、90822
- VA Long Beach Healthcare System
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Los Angeles、California、アメリカ、90036
- Peter J Ruane Md Inc
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Los Angeles、California、アメリカ、90069
- Anthony M. Mills Md Inc
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Los Angeles、California、アメリカ、90232
- Jeffrey Goodman Special Care Clinic
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San Diego、California、アメリカ、92114
- Precision Research Institute, LLC
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San Diego、California、アメリカ、92103
- UCSD AntiViral Research Center (AVRC)
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San Francisco、California、アメリカ、94110
- University of California San Francisco
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
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Washington、District of Columbia、アメリカ、20009
- Whitman Walker Health
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Washington、District of Columbia、アメリカ、20036
- Capital Medical Associates
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Florida
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Fort Pierce、Florida、アメリカ、34982
- Midway Immunology and Research Center
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Miami、Florida、アメリカ、33136
- University of Miami Schiff Center for Liver Diseases
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Orlando、Florida、アメリカ、32803
- Orlando Immunology Center
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Georgia
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Decatur、Georgia、アメリカ、30033
- Infect. Disease Specialists
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University Health - University Hospital
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Maryland
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Baltimore、Maryland、アメリカ、21229
- Digestive Disease Associates, P.A.
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Lutherville、Maryland、アメリカ、21093
- Johns Hopkins University
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Health System
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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New Mexico
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Sante Fe、New Mexico、アメリカ、87505
- Southwest CARE Center
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New York
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Binghamton、New York、アメリカ、13903
- Binghamton Gastroenterology Associates
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Cincinnati、Ohio、アメリカ、45267
- University of Cincinnati
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74135
- Healthcare Research Consultants
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Oregon
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Portland、Oregon、アメリカ、97239
- Oregon Health Science Univ
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Pennsylvania
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Allentown、Pennsylvania、アメリカ、18102
- Lehigh Valley Health Network
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Rhode Island
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Providence、Rhode Island、アメリカ、02906
- The Miriam Hospital
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Providence、Rhode Island、アメリカ、02905
- University Gastroenterology
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Texas
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Fort Worth、Texas、アメリカ、76104
- Tarrant County Inf Dis Assoc
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Houston、Texas、アメリカ、77030
- University of Texas Health Science Center at Houston
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Houston、Texas、アメリカ、77004
- Cure C Consortium
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Utah
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Murray、Utah、アメリカ、84123
- Clinical Research Centers Of America
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Virginia
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Richmond、Virginia、アメリカ、23249
- Mcguire D V A M C
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Washington
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Seattle、Washington、アメリカ、98104
- Harborview Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
- Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening
- Patients who are HCV treatment-naive
- Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening
- Patients with HCV RNA ≥10,000 IU/mL at screening
- Patients with HIV-1 infection
Key Exclusion Criteria:
- Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry
- Patients infected with HIV-2
- Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed
- Evidence of decompensated liver disease, including radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks
Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
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他の名前：
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実験的：Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks
Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks
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他の名前：
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実験的：Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks
Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
時間枠：At follow-up Week 12
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SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
時間枠：At follow-up Week 12
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SVR12 was defined as HCV RNA<lower limit of quantitation, target detected, or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
時間枠：At follow-up Week 12
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SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
時間枠：At follow-up Week 12
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SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24
時間枠：Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
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Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
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Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
時間枠：At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
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Participants with HCV RNA levels <LLOQ, TND.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
時間枠：At Follow-up Week 12
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SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.
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At Follow-up Week 12
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period
時間枠：AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
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AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period
時間枠：AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
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AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
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Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
時間枠：From screening up to week 24 of post treatment follow--up
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Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper
limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L
for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN
for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN
for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN
for grade 3 and >10.0*ULN for grade 4.
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From screening up to week 24 of post treatment follow--up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016 Jun 15;62(12):1489-96. doi: 10.1093/cid/ciw163. Epub 2016 Mar 29.
- Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年2月1日
一次修了 (実際)
2014年10月1日
研究の完了 (実際)
2015年1月1日
試験登録日
最初に提出
2014年1月9日
QC基準を満たした最初の提出物
2014年1月9日
最初の投稿 (見積もり)
2014年1月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月27日
QC基準を満たした最後の更新が送信されました
2015年9月24日
最終確認日
2015年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AI444-216
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。