Clinical trial NCT00686829: Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
Official title: Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With ≥1 Adverse Events (AEs)
timeFrame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
measure: Percentage of Participants Discontinuing Study Therapy Due to AEs
timeFrame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
measure: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
timeFrame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
measure: Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
timeFrame: Every 12 months up to 60 months
measure: Percentage of Participants With HIV RNA >50 to <400 Copies/mL
timeFrame: Every 12 months up to 60 months
measure: Percentage of Participants With HIV RNA ≥400 Copies/mL
timeFrame: Every 12 months up to 60 months
measure: Number of Participants With Coreceptor Tropism Shifts From Baseline
timeFrame: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
measure: Mean Change From Baseline in CD4/CD8 Cell Counts
timeFrame: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
measure: Number of Participants With Reduced Susceptibility to VCV
timeFrame: Up to time of VF in P4100, assessed up to approximately 5.5 years
measure: Number of Participants With AIDS-defining Events (ADEs)
timeFrame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
measure: Number of Participants With New Infections
timeFrame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wilkin TJ, Su Z, Krambrink A, Long J, Greaves W, Gross R, Hughes MD, Flexner C, Skolnik PR, Coakley E, Godfrey C, Hirsch M, Kuritzkes DR, Gulick RM. Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2010 Aug;54(5):470-6. doi: 10.1097/qai.0b013e3181e2cba0.
citation: Yeh TM, Evans SR, Gulick RM, Clifford DB. Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211. HIV Clin Trials. 2010 Jan-Feb;11(1):51-8. doi: 10.1310/hct1101-51.
citation: Tsibris AM, Paredes R, Chadburn A, Su Z, Henrich TJ, Krambrink A, Hughes MD, Aberg JA, Currier JS, Tashima K, Godfrey C, Greaves W, Flexner C, Skolnik PR, Wilkin TJ, Gulick RM, Kuritzkes DR. Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211. Clin Infect Dis. 2009 Mar 1;48(5):642-9. doi: 10.1086/597007.