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Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)

2020년 12월 2일 업데이트: Merck Sharp & Dohme LLC

Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211

The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

79

단계

  • 2 단계

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:

  • Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
  • Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
  • Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.

Exclusion Criteria:

  • History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
  • Female participants who are breast-feeding, pregnant, or plan to become pregnant
  • Participation in a clinical trial with another investigational drug.
  • Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: VCV 30 mg
Participants take VCV 30 mg once daily.
의약품: Vicriviroc maleate
VCV 30 mg tablet once daily by mouth.
다른 이름들:
  • SCH 417690

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With ≥1 Adverse Events (AEs)
기간: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants Discontinuing Study Therapy Due to AEs
기간: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
기간: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
기간: Every 12 months up to 60 months
The percentage of participants with HIV RNA <50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Every 12 months up to 60 months
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
기간: Every 12 months up to 60 months
The percentage of participants with HIV RNA >50 to <400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Every 12 months up to 60 months
Percentage of Participants With HIV RNA ≥400 Copies/mL
기간: Every 12 months up to 60 months
The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Every 12 months up to 60 months
Number of Participants With Coreceptor Tropism Shifts From Baseline
기간: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
Mean Change From Baseline in CD4/CD8 Cell Counts
기간: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
Number of Participants With Reduced Susceptibility to VCV
기간: Up to time of VF in P4100, assessed up to approximately 5.5 years
The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of <85% and relative MPI (R-MPI) values of <0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
Up to time of VF in P4100, assessed up to approximately 5.5 years
Number of Participants With AIDS-defining Events (ADEs)
기간: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Number of Participants With New Infections
기간: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
The number of participants with new infections is reported.
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

간행물 및 유용한 링크

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

일반 간행물

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 (실제)

2005년 6월 30일

기본 완료 (실제)

2010년 10월 21일

연구 완료 (실제)

2010년 10월 21일

연구 등록 날짜

최초 제출

2008년 5월 27일

QC 기준을 충족하는 최초 제출

2008년 5월 29일

처음 게시됨 (추정)

2008년 5월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 12월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 12월 2일

마지막으로 확인됨

2020년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • P04100
  • MK-7690-027 (기타 식별자: Merck Protocol Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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. .

HIV 감염에 대한 임상 시험

Vicriviroc maleate에 대한 임상 시험

유사한 임상시험 검색

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약물 개입

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약물 개입

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스폰서 / 협력자

위치

3
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