Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)

Last updated: December 2, 2020
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

2

Condition

Hiv

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT00686829
P04100
MK-7690-027
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successful completion of ACTG Protocol A5211, or favorable response in A5211 butdiscontinued due to tropism shift, or screened for A5211 and met inclusion/exclusioncriteria but unable to enroll due to protocol closure.
  • Participants must also be on a ritonavir-containing antiretroviral regimen at entry,and have acceptable hematologic and laboratory parameters.
  • Female participants of reproductive potential must agree to use 2 reliable methods ofcontraception, including a barrier method, and must have a negative urine pregnancytest prior to dosing.

Exclusion

Exclusion Criteria:

  • History of seizure or drug use that increases risk of seizure, current use of CYP3A4inducers, prior history of malignancy, active drug or alcohol use or dependence thatwould interfere with study requirements
  • Female participants who are breast-feeding, pregnant, or plan to become pregnant
  • Participation in a clinical trial with another investigational drug.
  • Participants with serious illness requiring systemic therapy and/or hospitalizationmust not begin VCV (if not already on VCV) until participant completes therapy or isclinically stable on therapy for at least 14 days prior to enrollment.

Study Design

Total Participants: 79
Study Start date:
June 30, 2005
Estimated Completion Date:
October 21, 2010