Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1) (Study P03672AM6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00243230
First received: October 20, 2005
Last updated: September 24, 2013
Last verified: September 2013

October 20, 2005
September 24, 2013
September 2005
October 2007   (final data collection date for primary outcome measure)
Log10 change from baseline in HIV RNA [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00243230 on ClinicalTrials.gov Archive Site
Proportion of subjects with >=1.0 log10 change from baseline in HIV RNA; Proportion of subjects with HIV RNA <400 copies/mL; Time to virologic failure [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1) (Study P03672AM6)
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1)

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways 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 HIV patients who have not responded adequately to standard HIV treatments. This study was designed to evaluate these doses of vicriviroc, when taken in combination with other appropriate HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood and safety

This is a randomized, double-blind, placebo controlled, parallel-group, multi-center study of vicriviroc maleate in HIV subjects 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 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 subject, 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 subjects 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 subjects have completed 48 weeks of treatment. After Week 48, subjects 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, subjects who discontinue early from the study prior to Week 48 will be offered re-screening for the open label segment of the study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Vicriviroc maleate 20 mg
    Two tablets of vicriviroc maleate 10 mg and one tablet of placebo once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc.
    Other Name: SCH 417690
  • Drug: Vicriviroc maleate 30 mg
    Three tablets of vicriviroc maleate 10 mg once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc.
    Other Name: SCH 417690
  • Drug: Placebo
    Three tablets of placebo once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc
  • Experimental: Vicriviroc 20 mg
    Intervention: Drug: Vicriviroc maleate 20 mg
  • Experimental: Vicriviroc 30 mg
    Intervention: Drug: Vicriviroc maleate 30 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2011
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects with documented HIV infection with no detectable CXCR4
  • Prior therapy for >=3 months with >=3 classes of currently marketed (US FDA-approved) antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
  • HIV 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 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 CNS condition or drug use predisposing to seizure in the opinion of the investigator
  • No active AIDS-defining opportunistic infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00243230
P03672, EudraCT number 2005-001057-21
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP