이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2010년 1월 7일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

252

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Dusseldorf, 독일
        • Local Institution
      • Hannover, 독일
        • Local Institution
      • Stuttgart, 독일
        • Local Institution
      • Ulm, 독일
        • Local Institution
  • 라트비아
      • Riga, 라트비아
        • Local Institution
  • 러시아 연방
      • Moscow, 러시아 연방
        • Local Institution
      • Smolensk, 러시아 연방
        • Local Institution
      • St. Petersburg, 러시아 연방
        • Local Institution
  • 스페인
      • Barcelona, 스페인
        • Local Institution
      • Madrid, 스페인
        • Local Institution
      • Valencia, 스페인
        • Local Institution
    • Alicante
      • Elche, Alicante, 스페인
        • Local Institution
  • 아일랜드
    • Dublin
      • Dublin 3, Dublin, 아일랜드
        • Local Institution
      • Dublin 8, Dublin, 아일랜드
        • Local Institution
  • 에스토니아
      • Tallinn, 에스토니아
        • Local Institution
  • 영국
    • Avon
      • Bristol, Avon, 영국
        • Local Institution
    • Central
      • Edinburgh, Central, 영국
        • Local Institution
    • Greater London
      • London, Greater London, 영국
        • Local Institution
  • 이탈리아
      • Brescia, 이탈리아
        • Local Institution
      • Milano, 이탈리아
        • Local Institution
      • Napoli, 이탈리아
        • Local Institution
      • Padova, 이탈리아
        • Local Institution
  • 포르투갈
      • Cascais, 포르투갈
        • Local Institution
      • Porto, 포르투갈
        • Local Institution
  • 프랑스
      • Le Kremlin Bicetre 94, 프랑스
        • Local Institution
      • Orleans, 프랑스
        • Local Institution
      • Paris, 프랑스
        • Local Institution
      • Paris Cedex 12, 프랑스
        • Local Institution
      • Paris Cedex 20, 프랑스
        • Local Institution
      • Suresnes, 프랑스
        • Local Institution

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Switch
ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)
의약품: 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)
다른 이름들:
  • 레야타즈
활성 비교기: Continuation
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
의약품: 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)
다른 이름들:
  • 레야타즈
다른: Rescue
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
의약품: 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)
다른 이름들:
  • 레야타즈

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: \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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bristol-Myers Squibb

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2005년 11월 1일

기본 완료 (실제)

2007년 8월 1일

연구 완료 (실제)

2008년 1월 1일

연구 등록 날짜

최초 제출

2005년 9월 16일

QC 기준을 충족하는 최초 제출

2005년 9월 20일

처음 게시됨 (추정)

2005년 9월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2010년 1월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2010년 1월 7일

마지막으로 확인됨

2010년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AI424-136

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다