Status:
COMPLETED
Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Acquire...
Eligibility Criteria
Inclusion
- Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria 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 of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.
Exclusion
- History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would 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 hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.
Key Trial Info
Start Date :
June 30 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00686829
Start Date
June 30 2005
End Date
October 21 2010
Last Update
December 3 2020
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