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Status:

COMPLETED

Safety and Effectiveness of the Oral HIV Entry Inhibitor Vicriviroc in HIV Infected Patients

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV dr...

Detailed Description

Vicriviroc is an oral HIV-1 entry inhibitor that targets the CCR5 receptor of T cells. Vicriviroc has been shown safe, well-tolerated, and active in Phase I clinical trials in treatment-naive HIV infe...

Eligibility Criteria

Inclusion

  • Note: This study was closed to screening on 09/20/05 and to enrollment on 10/20/05.
  • Inclusion Criteria for Step 1:
  • HIV infected
  • Experiencing virologic failure on current ART regimen
  • Current ART regimen contains ritonavir (100 to 800 mg/day) and has been stable for at least 8 weeks prior to study entry. If amprenavir or fosamprenavir is part of the regimen, 200 to 800 mg/day ritonavir must be used for at least 2 weeks prior to study entry.
  • Experienced virologic failure on at least one ART regimen containing 3 or more drugs prior to current failing regimen
  • CD4 count of 50 cells/mm3 or more within 6 weeks prior to study entry
  • HIV viral load of 5,000 copies/ml or more within 6 weeks prior to study entry
  • HIV strain of R5-only phenotype within 6 weeks prior to study entry
  • Willing to use acceptable forms of contraception
  • Able and willing to adhere to study dose and visit schedules
  • Inclusion Criteria for Step 2:
  • HIV viral load not suppressed by at least 1log10 below baseline viral load by Week 16 or after
  • QTc interval on EKG less than 500 msec, and less than 60 msec increase from baseline within 14 days of Step 2 entry
  • Inclusion Criteria for Step 3:
  • Use of vicriviroc in Step 1 or 2 of this study or the Schering rollover study. Participants who are currently not taking vicriviroc are eligible.
  • Exclusion Criteria for Step 1:
  • Hepatitis C antibody and RNA positive
  • Hepatitis B surface antigen positive
  • Efavirenz or nevirapine use within 8 weeks of study entry
  • Vaccination within 2 weeks prior to study screening
  • Investigational agents within 30 days prior to study entry
  • Systemic cancer chemotherapy or other systemic cytotoxic agents within 30 days prior to study entry
  • Immunosuppressants within 30 days prior to study entry. Systemic corticosteroids at replacement doses (10 mg/day prednisone or less) are not excluded.
  • Immunomodulators within 30 days prior to study entry
  • Considered at risk for seizure: history of seizure, recent history of head trauma with loss of consciousness, central nervous system (CNS) tumors, or other CNS problems that, in the opinion of the investigator, pose increased risk for seizure
  • Medications to prevent seizures or with the potential to cause seizures within 30 days prior to study entry
  • Allergy to SCH 417690 or its components
  • Alcohol or drug abuse that, in the opinion of the investigator, would interfere with the study
  • Serious illness requiring systemic treatment or hospitalization. A patient who is clinically stable on therapy is not excluded.
  • Any clinically significant disease or condition that, in the opinion of the investigator, may interfere with the study
  • Require certain medications
  • Pregnancy or breastfeeding
  • Exclusion Criteria for Step 2:
  • Have X4 or X4/R5 tropic virus, as determined by the HIV-1 coreceptor tropism assay
  • Intend to use efavirenz or nevirapine in background ART regimen
  • Allergy to vicriviroc or its formulations
  • Pregnancy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2011

    Estimated Enrollment :

    119 Patients enrolled

    Trial Details

    Trial ID

    NCT00082498

    Start Date

    May 1 2004

    End Date

    January 1 2011

    Last Update

    November 1 2021

    Active Locations (30)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (30 locations)

    1

    UCLA CARE Center CRS

    Los Angeles, California, United States, 90035

    2

    Stanford AIDS Clinical Trials Unit CRS

    Palo Alto, California, United States, 94304-5350

    3

    UCSD Antiviral Research Center CRS

    San Diego, California, United States, 92103

    4

    Ucsf Hiv/Aids Crs

    San Francisco, California, United States, 94110