NCT00243230|CompletedPhase 2ResultsDMCFDA Drug
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VICTOR-E1
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER · Merck Protocol Number
OTHER · Schering Corporation Protocol Number
NIH
interventional
116
0 countries
N/A
Study Start
September 19, 2005
Actual (reported)Primary Completion
October 19, 2007
Actual (reported)Study Completion
March 17, 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 17, 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 19, 2005
Actual (reported)October 20, 2005
Actual (reported)October 21, 2005
Actual (reported)October 19, 2007
Actual (reported)March 17, 2011
Actual (reported)June 8, 2021
Actual (reported)Change From Baseline in Log10 Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at 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
Participants With ≥1.0 log10 Change From Baseline HIV RNA at Week 48 of the Double-blind Period
Baseline and 48 Weeks of the Double-blind Period
Participants With HIV RNA <400 Copies/mL at Week 48 of the Double-blind Period
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
Up to 48 weeks of the Double-blind Period
Change From Baseline in Log10 HIV RNA at Week 12 of the Double-blind Period
Baseline and Week 12 of the Double-blind Period
Change From Baseline in Log10 HIV RNA at Week 24 of the Double-blind Period
Baseline and Week 24 of the Double-blind Period
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.
Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period).
Suleiman J, Zingman BS, Diaz RS, Madruga JV, DeJesus E, Slim J, Mak C, Lee E, McCarthy MC, Dunkle LM, Walmsley S. Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects: 48-week results of the VICTOR-E1 phase 2 trial. J Infect Dis. 2010 Feb 15;201(4):590-9. doi: 10.1086/650342.
Medical Director
Merck Sharp & Dohme LLC
116 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2005
First Posted
October 21, 2005
Study Start
September 19, 2005
Actual (reported)Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks.
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.
Two tablets of vicriviroc 10 mg once daily for 48 weeks.
Three tablets of placebo once daily for 48 weeks.
Two tablets of placebo once daily for 48 weeks.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 19, 2007
Actual (reported)Study Completion
March 17, 2011
Actual (reported)Last Updated
June 8, 2021
Results First Posted
June 8, 2021
Record last verified: 2021-05
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Source: ClinicalTrials.gov.
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