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Clinical Trials

MainTitle

Vicriviroc in HIV-Treatment Experienced Subjects (Study P04889AM8)(COMPLETED)

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT00474370

First received: May 15, 2007
Last updated: December 18, 2015
Last Verified: December 2015
History of Changes
Purpose

Purpose

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). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to confirm the previous findings in a larger phase 3 study over a 48-week period, and show that when taken in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV (viral load) in the blood and that it is well tolerated.

Condition Intervention Phase
HIV Infections
Acquired Immunodeficiency Syndrome

Drug : Vicriviroc
Drug : Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Proportion of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL) [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • Mean change from baseline in plasma HIV-1 RNA (log10 copies/mL); Proportion of subjects with <400 copies/mL of plasma HIV-1 RNA; Proportion of subjects with at least 2log10 reduction from baseline in plasma HIV-1 RNA [ Time Frame: 48 weeks ]

Enrollment: 400
Study Start Date: May 2007
Study Completion Date: October 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Test Arm
Vicriviroc 30 mg QD
Drug: Vicriviroc

One tablet of vicriviroc 30 mg once daily.

Other Name: SCH 417690
Placebo Comparator: Placebo Control Arm
Placebo
Drug: Placebo

One tablet of placebo once daily.

Detailed Description:

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 and who have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or PI) or at least 6 months experience with at
least 2 of the following: one NRTI, one NNRTI, or two PIs (excluding low-dose ritonavir)and failed at least one standard triple-drug regimen. The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening, history of prior antiretroviral drug use by the patient, and drug toxicity. OBT must include a PI boosted by ritonavir (>=100 mg of ritonavir), and at least 2 active drugs (ie, to which HIV isolate is fully susceptible). Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. An interim analysis will be performed when all subjects have completed 24 weeks of treatment. After completing Week 48 of the study, subjects will be offered open-label vicriviroc 30 mg QD, if appropriate, until the drug is commercially available or until the sponsor terminates the clinical development of vicriviroc. Additionally, subjects who discontinued early from the study prior to Week 48 may be eligible for the open-label segment of the study.

Eligibility

Eligibility

Ages Eligible for Study: 16 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Subject must be infected with HIV-1 virus.
  • Subject must have documented plasma HIV-1 RNA >1000 copies/mL within 60 days of Visit 1/Day 1 (randomization) and must be either
    • on a stable regimen of 3 or more antiretrovirals (ART) for at least 4

    • weeks prior to the screening visit
      OR
  • on no ART agents for at least 4 weeks prior to

  • the screening visit.
  • Subject must be ART experienced and have documented resistance to at least 2 of the following 3 drug classes: nucleoside reverse transcriptase inhibitor (NRTI); non-nucleoside reverse transcriptase inhibitor (NNRTI); or protease inhibitor (PI)

  • OR
    Subject must have ART class experience for at least 6 months with at least two of the following: one NRTI; one NNRTI; two PIs (excluding low-dose ritonavir).
  • Women of child-bearing potential must agree to use a medically accepted method of contraceptive as defined by the protocol.
  • Subject must be willing to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infection as defined in protocol.


Exclusion Criteria:
  • Subjects with detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening.
  • Subjects with prior history of malignancy (with 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); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy.
  • Subjects with seizure disorder requiring anti-seizure therapy or with any condition
that is likely to increase risk of seizure (CNS malignancy or toxoplasmosis).

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474370

Sponsors and Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT00474370   History of Changes  
Other Study ID Numbers: P04889  
  3547030  
Study First Received: May 15, 2007  
Last Updated: December 18, 2015  

Keywords provided by Merck Sharp & Dohme Corp.:

Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.