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Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study) (INDUMA)

2010年1月7日 更新者：Bristol-Myers Squibb

A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)

The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

252

段階

  • フェーズ 4

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

  • アイルランド
    • Dublin
      • Dublin 3、Dublin、アイルランド
        • Local Institution
      • Dublin 8、Dublin、アイルランド
        • Local Institution
  • イギリス
    • Avon
      • Bristol、Avon、イギリス
        • Local Institution
    • Central
      • Edinburgh、Central、イギリス
        • Local Institution
    • Greater London
      • London、Greater London、イギリス
        • Local Institution
  • イタリア
      • Brescia、イタリア
        • Local Institution
      • Milano、イタリア
        • Local Institution
      • Napoli、イタリア
        • Local Institution
      • Padova、イタリア
        • Local Institution
  • エストニア
      • Tallinn、エストニア
        • Local Institution
  • スペイン
      • Barcelona、スペイン
        • Local Institution
      • Madrid、スペイン
        • Local Institution
      • Valencia、スペイン
        • Local Institution
    • Alicante
      • Elche、Alicante、スペイン
        • Local Institution
  • ドイツ
      • Dusseldorf、ドイツ
        • Local Institution
      • Hannover、ドイツ
        • Local Institution
      • Stuttgart、ドイツ
        • Local Institution
      • Ulm、ドイツ
        • Local Institution
  • フランス
      • Le Kremlin Bicetre 94、フランス
        • Local Institution
      • Orleans、フランス
        • Local Institution
      • Paris、フランス
        • Local Institution
      • Paris Cedex 12、フランス
        • Local Institution
      • Paris Cedex 20、フランス
        • Local Institution
      • Suresnes、フランス
        • Local Institution
  • ポルトガル
      • Cascais、ポルトガル
        • Local Institution
      • Porto、ポルトガル
        • Local Institution
  • ラトビア
      • Riga、ラトビア
        • Local Institution
  • ロシア連邦
      • Moscow、ロシア連邦
        • Local Institution
      • Smolensk、ロシア連邦
        • Local Institution
      • St. Petersburg、ロシア連邦
        • Local Institution

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

Inclusion Criteria:

  • Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).
  • Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
  • Subjects who have a CD4 count ≥ 50 cells/mm3.
  • Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
  • Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
  • WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
  • Primary HIV infection
  • Medical History and Concurrent Diseases
  • Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
  • Screening laboratory values measured as follows:
  • Grade IV glucose,
  • Grade IV electrolytes,
  • Grade IV transaminases,
  • Grade IV hematology.
  • Hypersensitivity to any component of the formulation of study drug
  • Prior history of taking any ARV for more than 10 days
  • Concomitant administration of tenofovir (TDF).
  • Refer to Section 6.4.1 which details all prohibited therapies

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
アクティブコンパレータ：Switch
ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)
薬：Atazanavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
他の名前：
  • レヤタズ
アクティブコンパレータ：Continuation
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
薬：Atazanavir + Ritonavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
他の名前：
  • レヤタズ
他の：Rescue
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
薬：Atazanavir + Ritonavir + 2 NRTIs
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
他の名前：
  • レヤタズ

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
Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
時間枠：From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.
From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase
時間枠：From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.
From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
時間枠：Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.
Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
時間枠：Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.
Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase
時間枠：End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase
Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.
End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase
Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase
時間枠：Baseline, Week 24 of Induction Phase
Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.
Baseline, Week 24 of Induction Phase
Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase
時間枠：Baseline, Week 48 of Rescue Phase
Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.
Baseline, Week 48 of Rescue Phase
Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase
時間枠：Baseline, Week 24 of Induction Phase
Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.
Baseline, Week 24 of Induction Phase
Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase
時間枠：\Baseline, Week 48 of Rescue Phase
Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.
\Baseline, Week 48 of Rescue Phase
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
時間枠：Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.
Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.
Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.
Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
時間枠：Baseline, Week 48 of Rescue Phase
Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.
Baseline, Week 48 of Rescue Phase
Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
時間枠：Week 16-18, Week 24-26, Week 38-40, Week 64-66
Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.
Week 16-18, Week 24-26, Week 38-40, Week 64-66
Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
時間枠：Week 16-18, Week 24-26, Week 30-32
Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.
Week 16-18, Week 24-26, Week 30-32
Summary of Adverse Events During Induction Phase
時間枠：Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).
Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).
Summary of Adverse Events During Maintenance Phase
時間枠：Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.
Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.
Summary of Adverse Events During Rescue Phase
時間枠：Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.
Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.
Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
時間枠：Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.
Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.
Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.

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

Bristol-Myers Squibb

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

2005年11月1日

一次修了 (実際)

2007年8月1日

研究の完了 (実際)

2008年1月1日

試験登録日

最初に提出

2005年9月16日

QC基準を満たした最初の提出物

2005年9月20日

最初の投稿 (見積もり)

2005年9月21日

学習記録の更新

投稿された最後の更新 (見積もり)

2010年1月12日

QC基準を満たした最後の更新が送信されました

2010年1月7日

最終確認日

2010年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AI424-136

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。

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