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Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672) (VICTOR-E1)

2021년 5월 12일 업데이트: Merck Sharp & Dohme LLC

Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1)

Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of vicriviroc in participants with HIV who have not responded adequately to standard HIV treatments. This study was designed to evaluate the safety and efficacy of doses of vicriviroc, when taken in combination with other HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood. The primary objective of the study was to evaluate antiviral efficacy of two doses of Vicriviroc maleate compared to placebo in combination with a protease inhibitor (PI)-containing optimized antiretroviral therapy (ART) regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a randomized, double-blind, placebo controlled, parallel-group, multi-center study of vicriviroc maleate in participants with HIV infected with CCR5-tropic virus only for whom standard antiretroviral treatment (ART) has failed. The study will evaluate the antiviral efficacy of two doses of vicriviroc (20 mg once daily (QD) and 30 mg QD) compared with placebo when added to optimized ART therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests, history of prior antiretroviral drug use by the participant, and drug toxicity. The background regimen must include at least 3 antiretroviral drugs (not including study drug), one of which must be a ritonavir-boosted protease inhibitor (≥100 mg ritonavir). There will be two interim analyses: when all participants have completed 12 weeks and 24 weeks of treatment, respectively. Based on the balance of safety and efficacy determined in these analyses, a dosage or dosages will be selected for further study in additional registrational trials. The primary efficacy analysis will be conducted when all participants have completed 48 weeks of treatment. After Week 48, participants who meet applicable criteria will be offered open label vicriviroc 30 mg QD, if appropriate, until the sponsor terminates the clinical development of vicriviroc. Additionally, participants who discontinue early from the study prior to Week 48 will be offered re-screening for the open label segment of the study.

연구 유형

중재적

등록 (실제)

116

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:

  • Adult participants with documented HIV infection with no detectable C-X-C Motif Chemokine Receptor 4 (CXCR4)
  • Prior therapy for ≥3 months with ≥3 classes of currently marketed (US FDA-approved) antiretroviral agents (nucleoside reverse transcriptase inhibitor, NRTIs, non-nucleoside reverse transcriptase inhibitor (NNRTIs), protease inhibitor (PIs), or fusion inhibitors) at any time prior to screening
  • HIV ribonucleic acid (RNA) ≥1000 copies/mL on a stable ART regimen for ≥6 weeks prior to Screening and ≥8 weeks prior to randomization
  • ≥1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and ≥1 primary resistance mutation to a PI
  • Acceptable hematologic, renal and hepatic laboratory parameters

Exclusion Criteria:

  • No history of previous malignancy (with the exceptions of cutaneous Kaposi's Sarcoma without visceral or mucosal involvement that resolved with highly active antiretroviral therapy (HAART) but without systemic anti-cancer treatment, and basal-cell carcinoma of skin surgically resected with disease-free margins on pathology exam)
  • Treatment with cytotoxic cancer chemotherapy,
  • Recurrent seizure, or central nervous system (CNS) condition or drug use predisposing to seizure in the opinion of the investigator
  • No active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection

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: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Double-Blind - Vicriviroc 30 mg
Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks.
의약품: Vicriviroc 30 mg
Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).
다른 이름들:
  • SCH 417690
의약품: Background ART Regimen
An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor [PI]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.
실험적: Double-Blind - Vicriviroc 20 mg
Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
의약품: Background ART Regimen
An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor [PI]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.
의약품: Vicriviroc 20 mg
Two tablets of vicriviroc 10 mg once daily for 48 weeks.
다른 이름들:
  • SCH 417690
의약품: Placebo
Three tablets of placebo once daily for 48 weeks.
의약품: Placebo
Two tablets of placebo once daily for 48 weeks.
위약 비교기: Double-Blind - Placebo
Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
의약품: Background ART Regimen
An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor [PI]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.
의약품: Placebo
Three tablets of placebo once daily for 48 weeks.
의약품: Placebo
Two tablets of placebo once daily for 48 weeks.
실험적: Open-label - Vicriviroc 30 mg
Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized ART regimen containing a ritonavir-boosted protease inhibitor (PI/r) for up to 45 months.
의약품: Vicriviroc 30 mg
Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).
다른 이름들:
  • SCH 417690
의약품: Background ART Regimen
An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor [PI]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Log10 Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Week 48 of the Double-blind Period
기간: Baseline and Week 48 of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 copies/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero. Analysis was performed with a variance (ANOVA) model that adjusted for the treatment and stratification factors (intended enfuvirtide (T20) use in current newly-optimized background regimen (OBT) (Y/N) and HIV RNA at Screening (> or ≤100,000 copies/mL)).
Baseline and Week 48 of the Double-blind Period

2차 결과 측정

결과 측정
측정값 설명
기간
Participants With ≥1.0 log10 Change From Baseline HIV RNA at Week 48 of the Double-blind Period
기간: Baseline and 48 Weeks of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 copies/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero.
Baseline and 48 Weeks of the Double-blind Period
Participants With HIV RNA <400 Copies/mL at Week 48 of the Double-blind Period
기간: Week 48 of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero.
Week 48 of the Double-blind Period
Participants With a Time to Loss of Virologic Response (TLOVR) Based on 0.5 Log10 Reduction by 48 Weeks of the Double-blind Period
기간: Up to 48 weeks of the Double-blind Period
TLOVR defined as the time from randomization to either: 1. Failure to experience HIV RNA decline of ≥0.5 log10 from Baseline at Week 4, in which case time was set to 0; or 2. Rebound of HIV RNA to within 0.5 log10 of baseline value at any time after maximum suppression. HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 c/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 c/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero.
Up to 48 weeks of the Double-blind Period
Change From Baseline in Log10 HIV RNA at Week 12 of the Double-blind Period
기간: Baseline and Week 12 of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 c/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 c/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. Missing values of change from baseline were imputed by the average of immediately preceding and following non-missing values, and in any other cases, missing values were imputed by zero.
Baseline and Week 12 of the Double-blind Period
Change From Baseline in Log10 HIV RNA at Week 24 of the Double-blind Period
기간: Baseline and Week 24 of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 c/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 c/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. Missing values of change from baseline were imputed by the average of immediately preceding and following non-missing values, and in any other cases, missing values were imputed by zero.
Baseline and Week 24 of the Double-blind Period
Change From Baseline CD4 Cells Count at Week 12 of the Double-blind Period
기간: Baseline and Week 12 of the Double-blind Period
Blood was collected and CD4+ cell count assessment was done by flow cytometry. Mean change from baseline in CD4 cell counts was determined. Any missing value was replaced by carrying forward baseline except if the immediately preceding and following value are available, in which case the arithmetic average of the two was used. If more than 1 CD4 count was available during a visit window, the value that was the closest to the time point of interest was used. If more than 1 pre-treatment CD4 value was available at baseline, the arithmetic mean of the 2 CD4 counts was taken.
Baseline and Week 12 of the Double-blind Period
Change From Baseline CD4 Count at Week 24 of the Double-blind Period
기간: Baseline and Week 24 of the Double-blind Period
Blood was collected and CD4+ cell count assessment was done by flow cytometry. Mean change from baseline in CD4 cell counts was determined. Any missing value was replaced by carrying forward baseline except if the immediately preceding and following value are available, in which case the arithmetic average of the two was used. If more than 1 CD4 count was available during a visit window, the value that was the closest to the time point of interest was used. If more than 1 pre-treatment CD4 value was available at baseline, the arithmetic mean of the 2 CD4 counts was taken.
Baseline and Week 24 of the Double-blind Period
Change From Baseline CD4 Count at Week 48 of the Double-blind Period
기간: Baseline and Week 48 of the Double-blind Period
Blood was collected and CD4+ cell count assessment was done by flow cytometry. Mean change from baseline in CD4 cell counts was determined. Any missing value was replaced by carrying forward baseline except if the immediately preceding and following value are available, in which case the arithmetic average of the two was used. If more than 1 CD4 count was available during a visit window, the value that was the closest to the time point of interest was used. If more than 1 pre-treatment CD4 value was available at baseline, the arithmetic mean of the 2 CD4 counts was taken.
Baseline and Week 48 of the Double-blind Period
Change From Baseline CD4 Count at Month 42 of the Open Label Extension
기간: Baseline and Month 42 of the Open Label Period
Blood was collected and CD4+ cell count assessment was done by flow cytometry. Mean change from baseline in CD4 cell counts was determined. Any missing value was replaced by carrying forward baseline except if the immediately preceding and following value are available, in which case the arithmetic average of the two was used. If more than 1 CD4 count was available during a visit window, the value that was the closest to the time point of interest was used. If more than 1 pre-treatment CD4 value was available at baseline, the arithmetic mean of the 2 CD4 counts was taken. After completion of the Double-Blind Period, eligible participants could enroll in the Open Label Period and continue treatment.
Baseline and Month 42 of the Open Label Period
Participants With <400 Copies/mL HIV RNA at Week 12 of the Double-blind Period
기간: Week 12 of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero. HIV RNA <400 copies/mL is a less stringent measure of viral suppression and indicates that a participant responded to treatment.
Week 12 of the Double-blind Period
Participants With <400 Copies/mL HIV RNA at Week 24 of the Double-blind Period
기간: Week 24 of the Double-blind Period
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero. HIV RNA <400 copies/mL is a less stringent measure of viral suppression and indicates that a participant responded to treatment.
Week 24 of the Double-blind Period
Number of Participants With <50, 50 to <400, and ≥400 Copies/mL HIV RNA of the Open Label Extension
기간: Up to 45 months of the Open Label Extension
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay (the lower quantification, [LOQ of 400 copies/mL]) and for HIV RNA below the LOQ, with the AMPLICOR HIV-1.5 UltraSensitive assay. HIV RNA <400 copies/mL is a less stringent measure of viral suppression (participant responded to treatment). HIV RNA < 50 copies/mL is a very stringent measure of viral suppression (participant achieved full virologic suppression). If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. Missing value for any reason will be imputed as non-responder except if the immediately preceding and following viral counts are both <50 copies/mL. Results are shown for Group 1. for participants with baseline HIV RNA <50 copies/mL, Group 2. baseline HIV RNA 50 to <400 copies/mL, and Group 3. baseline HIV RNA>400 copies/mL.
Up to 45 months of the Open Label Extension
Participants With <50 Copies/mL HIV RNA at Week 12 of the Double-blind Period
기간: Week 12 of the Double-blind Period
The lower limit of HIV RNA <50 copies/mL was determined by the UltraSensitive assay. HIV RNA <50 copies/mL is a very stringent measure of viral suppression and indicates that a participant achieved full virologic suppression. Missing value for any reason were imputed as non-responder except if the immediately preceding and following viral counts are both <50 copies/mL.
Week 12 of the Double-blind Period
Participants With <50 Copies/mL HIV RNA at Week 24 of the Double-blind Period
기간: Week 24 of the Double-blind Period
The lower limit of HIV RNA <50 copies/mL was determined by the UltraSensitive assay. HIV RNA < 50 copies/mL is a very stringent measure of viral suppression and indicates that a participant achieved full virologic suppression. Missing value for any reason will be imputed as non-responder except if the immediately preceding and following viral counts are both <50 copies/mL.
Week 24 of the Double-blind Period
Participants With <50 Copies/mL HIV RNA at Week 48 of the Double-blind Period
기간: Week 48 of the Double-blind Period
The lower limit of HIV RNA <50 copies/mL was determined by the UltraSensitive assay. HIV RNA <50 copies/mL is a very stringent measure of viral suppression and indicates that a participant achieved full virologic suppression. Missing value for any reason were imputed as non-responder except if the immediately preceding and following viral counts are both <50 copies/mL.
Week 48 of the Double-blind Period
Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Events of the Double-blind Period
기간: Up to 48 weeks of the Double-blind Period
All potential AIDS-defining events (ADEs) identified by investigators and the sponsor were submitted with supporting clinical data to an Adjudication Committee of HIV experts. These experts did not participant in the study and reviewed the data without knowledge of treatment assignment. To be analyzed as an ADE, the event required concurrence on the diagnosis by at least two of the three Adjudication Committee members. Their review consisted of available clinical and laboratory data, including relevant radiologic, endoscopic, and pathology assessments, when applicable as well as autopsy reports and/or hospital admission and discharge summaries. An independent radiologist was called upon when necessary. Guidelines for Diagnosis of AIDS-Defining Conditions (CDC's 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults) was used.
Up to 48 weeks of the Double-blind Period
Participants With AIDS-defining Events of the Open Label Extension
기간: Up to 45 months of the Open Label Extension
All potential AIDS-defining events (ADEs) identified by investigators and the sponsor were submitted with supporting clinical data to an Adjudication Committee of HIV experts, who did not participant in the study and reviewed the blinded data. Their review consisted of available clinical and laboratory data, including relevant radiologic, endoscopic, and pathology assessments, autopsy reports and/or hospital admission and discharge summaries. An independent radiologist was called upon when necessary. Guidelines for Diagnosis of AIDS-Defining Conditions (CDC's 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults) was used. To be analyzed as an ADE, the event required concurrence on the diagnosis by at least 2 of 3 Adjudication Committee members. After completion of the Double-blind Period, eligible participants could enroll in the Open Label Period and continue treatment.
Up to 45 months of the Open Label Extension
Time to Occurrence of an AIDS-defining Event of the Double-blind Period
기간: Up to 48 weeks of the Double-blind Period
All potential AIDS-defining events (ADEs) identified by investigators and the sponsor were submitted with supporting clinical data to an independent and blinded Adjudication Committee of HIV experts. To be analyzed as an ADE, the event required concurrence on the diagnosis by at least 2 of the 3 Adjudication Committee members. Their review included available clinical and laboratory data, including relevant radiologic, endoscopic, and pathology assessments, when applicable as well as autopsy reports and/or hospital admission and discharge summaries. An independent radiologist was called upon when necessary. Guidelines for Diagnosis of AIDS-Defining Conditions (CDC's 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults) was used.
Up to 48 weeks of the Double-blind Period
Observed Minimum Serum Concentration of Vicriviroc (Cmin) of the Double-blind Period
기간: Two blood samples 2 hours apart on Week 4, Week 12, and Week 24 of the Double-blind Period
Key pharmacokinetic (PK) parameters (maximum plasma concentration [Cmax], minimum plasma concentration [Cmin], area under the plasma concentration-time curve [AUC]) were estimated using a population PK modeling approach based on a two-compartment model with first-order absorption and elimination. Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. Pharmacokinetics studies were not performed with participants receiving Placebo.
Two blood samples 2 hours apart on Week 4, Week 12, and Week 24 of the Double-blind Period
Observed Maximum (Peak) Plasma Concentration of Vicriviroc (Cmax) of the Double-blind Period
기간: Two blood samples 2 hours apart on Week 4, Week 12, and Week 24 of the Double-blind Period
Key pharmacokinetic (PK) parameters (maximum plasma concentration [Cmax], minimum plasma concentration [Cmin], area under the plasma concentration-time curve [AUC]) were estimated using a population PK modeling approach based on a two-compartment model with first-order absorption and elimination. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Pharmacokinetics studies were not performed with participants receiving Placebo.
Two blood samples 2 hours apart on Week 4, Week 12, and Week 24 of the Double-blind Period
Area Under the Plasma Concentration Versus Time Curve of Vicriviroc (AUC) of the Double-blind Period
기간: Two blood samples 2 hours apart on Week 4, Week 12, and Week 24 of the Double-blind Period
Key pharmacokinetic (PK) parameters (maximum plasma concentration [Cmax], minimum plasma concentration [Cmin], area under the plasma concentration-time curve [AUC]) were estimated using a population PK modeling approach based on a two-compartment model with first-order absorption and elimination. AUC is a measure of the mean concentration levels of drug in the plasma after the dose. Pharmacokinetics studies were not performed with participants receiving Placebo.
Two blood samples 2 hours apart on Week 4, Week 12, and Week 24 of the Double-blind Period
Participants With Detectable Vicriviroc Resistance of the Double-blind Period
기간: Up to 48 weeks of the Double-blind Period
Resistance testing was performed at Baseline and again at the time of virologic failure or study discontinuation using the Phenosense GT assay (Monogram Biosciences, South San Francisco, CA). This assay used a combination of genotypic and phenotypic resistance techniques to determine an overall sensitivity score (OSS). The OSS represents the total number of drugs in the optimized background regimen (OBT) to which the virus was fully susceptible. Partial sensitivity is not counted towards the OSS. VCV susceptibility testing was performed with a maximal percent inhibition (MPI) plateau value of <85% as a cutoff for resistance.
Up to 48 weeks of the Double-blind Period
Participants With Detectable C-X-C Chemokine Receptor Type 4 (CXCR4)-Tropic Virus of the Double-blind Period
기간: Up to 48 weeks of the Double-blind Period
Viral tropism was determined using the Monogram Trofile assay and antiviral drug susceptibility was measured by Monogram PhenoSense GT assay, based on both genotypic and phenotypic sensitivity of HIV isolates. The lower limit of sensitivity of the Trofile assay employed in this study for detection of minor X-4 using variants was 5-10%.
Up to 48 weeks of the Double-blind Period
Participants With Detectable CXCR4-Tropic Virus and Immune Decline (≥50% Fall in CD4 Count From Baseline) of the Double-blind Period
기간: Up to 48 weeks of the Double-blind Period
Viral tropism was determined using the Monogram Trofile assay and antiviral drug susceptibility was measured by Monogram PhenoSense GT assay, based on both genotypic and phenotypic sensitivity of HIV isolates. The lower limit of sensitivity of the Trofile assay employed in this study for detection of minor X-4 using variants was 5-10%. Participants with emergence of CXCR4 tropism who had a concomitant decline in CD4 count by ≥50% below baseline was also computed.
Up to 48 weeks of the Double-blind Period

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 9월 19일

기본 완료 (실제)

2007년 10월 19일

연구 완료 (실제)

2011년 3월 17일

연구 등록 날짜

최초 제출

2005년 10월 20일

QC 기준을 충족하는 최초 제출

2005년 10월 20일

처음 게시됨 (추정)

2005년 10월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 6월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 12일

마지막으로 확인됨

2021년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • P03672 (기타 식별자: Schering Corporation Protocol Number)
  • 2005-001057-21 (EudraCT 번호)
  • MK-7690-020 (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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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 30 mg에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Norway

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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