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

A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

2012년 6월 8일 업데이트: ViiV Healthcare

Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

129

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일, 12157
        • Pfizer Investigational Site
      • Berlin, 독일, 10243
        • Pfizer Investigational Site
      • Frankfurt am Main, 독일, 60590
        • Pfizer Investigational Site
      • Hamburg, 독일, 20146
        • Pfizer Investigational Site
      • Koeln, 독일, 50937
        • Pfizer Investigational Site
      • Muenchen, 독일, 80335
        • Pfizer Investigational Site
  • 미국
    • California
      • Los Angeles, California, 미국, 90048
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90069
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90027
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90028
        • Pfizer Investigational Site
    • Connecticut
      • Norwalk, Connecticut, 미국, 06851
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, 미국, 20009
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, 미국, 33136
        • Pfizer Investigational Site
      • Miami, Florida, 미국, 33133
        • Pfizer Investigational Site
      • Miami, Florida, 미국, 33137
        • Pfizer Investigational Site
      • Orlando, Florida, 미국, 32803
        • Pfizer Investigational Site
      • Pensacola, Florida, 미국, 32504
        • Pfizer Investigational Site
      • St. Petersburg, Florida, 미국, 33713
        • Pfizer Investigational Site
      • Tampa, Florida, 미국, 33602
        • Pfizer Investigational Site
      • Tampa, Florida, 미국, 33614
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국, 30312
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, 미국, 60657
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, 미국, 01107
        • Pfizer Investigational Site
      • Springfield, Massachusetts, 미국, 01199
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, 미국, 68106
        • Pfizer Investigational Site
    • New York
      • New York, New York, 미국, 10003
        • Pfizer Investigational Site
    • North Carolina
      • Huntersville, North Carolina, 미국, 28078
        • Pfizer Investigational Site
    • Texas
      • Addison, Texas, 미국, 75001
        • Pfizer Investigational Site
      • Dallas, Texas, 미국, 75204
        • Pfizer Investigational Site
      • Dallas, Texas, 미국, 75390
        • Pfizer Investigational Site
      • Houston, Texas, 미국, 77098
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, 미국, 99204
        • Pfizer Investigational Site
  • 스페인
      • Alicante, 스페인, 03010
        • Pfizer Investigational Site
      • Barcelona, 스페인, 08036
        • Pfizer Investigational Site
      • Cordoba, 스페인, 14004
        • Pfizer Investigational Site
      • Madrid, 스페인, 28046
        • Pfizer Investigational Site
      • Sevilla, 스페인, 41013
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, 스페인, 08907
        • Pfizer Investigational Site

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

16년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
  • CD4 count ≥100 cells/mm3 at Screening.
  • Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.

Exclusion Criteria:

  • Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
  • Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
  • X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.

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
실험적: Arm A
maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study.
의약품: maraviroc
maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
다른 이름들:
  • maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista
의약품: maraviroc
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
다른 이름들:
  • maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia
실험적: Arm B

emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD

Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.
의약품: maraviroc
maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
다른 이름들:
  • maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista
의약품: maraviroc
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
다른 이름들:
  • maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
기간: Week 48
Week 48

2차 결과 측정

결과 측정
측정값 설명
기간
HIV-1 RNA Levels at Baseline
기간: Baseline
Baseline
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
기간: Baseline , Days 4, 7, 10 and 14
Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
Baseline , Days 4, 7, 10 and 14
Maximum Observed Plasma Concentration (Cmax) of Maraviroc
기간: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Minimum Observed Plasma Concentration (Cmin) of Maraviroc
기간: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Average Observed Plasma Concentration (Cavg) of Maraviroc
기간: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
기간: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
기간: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
기간: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Time to Loss of Virological Response (TLOVR)
기간: Baseline through Week 96
TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
Baseline through Week 96
Time-Averaged Difference (TAD) in log10 Viral Load
기간: Week 16, Week 24, Week 48, Week 96
TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
Week 16, Week 24, Week 48, Week 96
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
기간: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
기간: Baseline, Week 16, Week 24, Week 48, Week 96
Baseline, Week 16, Week 24, Week 48, Week 96
Number of Participants With Genotypic Resistance
기간: Week 96 or Time of treatment failure
Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Week 96 or Time of treatment failure
Number of Participants With Phenotypic Resistance
기간: Week 96 or Time of treatment failure
Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Week 96 or Time of treatment failure
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
기간: Baseline to Week 96 or Time of treatment Failure
Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.
Baseline to Week 96 or Time of treatment Failure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

ViiV Healthcare

협력자

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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

2009년 3월 1일

기본 완료 (실제)

2010년 7월 1일

연구 완료 (실제)

2011년 7월 1일

연구 등록 날짜

최초 제출

2009년 1월 21일

QC 기준을 충족하는 최초 제출

2009년 1월 21일

처음 게시됨 (추정)

2009년 1월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 6월 8일

마지막으로 확인됨

2012년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A4001078

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. .

maraviroc에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Slovenia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다