- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00686829
Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
December 2, 2020 updated by: Merck Sharp & Dohme LLC
Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VCV 30 mg
Participants take VCV 30 mg once daily.
|
VCV 30 mg tablet once daily by mouth.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With ≥1 Adverse Events (AEs)
Time Frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
|
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
Percentage of Participants Discontinuing Study Therapy Due to AEs
Time Frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
|
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
Time Frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
|
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Time Frame: Every 12 months up to 60 months
|
The percentage of participants with HIV RNA <50 copies/mL at each time point is reported.
For this measure, "month" was defined as each 28-day period on study treatment.
The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
|
Every 12 months up to 60 months
|
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Time Frame: Every 12 months up to 60 months
|
The percentage of participants with HIV RNA >50 to <400 copies/mL at each time point is reported.
For this measure, "month" was defined as each 28-day period on study treatment.
The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
|
Every 12 months up to 60 months
|
Percentage of Participants With HIV RNA ≥400 Copies/mL
Time Frame: Every 12 months up to 60 months
|
The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported.
For this measure, "month" was defined as each 28-day period on study treatment.
The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
|
Every 12 months up to 60 months
|
Number of Participants With Coreceptor Tropism Shifts From Baseline
Time Frame: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
|
The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported.
The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
|
Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
|
Mean Change From Baseline in CD4/CD8 Cell Counts
Time Frame: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
|
The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported.
"Month" was defined as each 28-day period on study treatment.
A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes.
The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
|
Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
|
Number of Participants With Reduced Susceptibility to VCV
Time Frame: Up to time of VF in P4100, assessed up to approximately 5.5 years
|
The total number of participants with viruses having phenotypic resistance to VCV is reported.
Viruses exhibiting both maximum percent inhibition (MPI) plateau values of <85% and relative MPI (R-MPI) values of <0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
|
Up to time of VF in P4100, assessed up to approximately 5.5 years
|
Number of Participants With AIDS-defining Events (ADEs)
Time Frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
The number of participants with ADEs is reported.
An ADE is an SAE that is expected in the course of disease and not considered related to study intervention.
The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
|
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
Number of Participants With New Infections
Time Frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
The number of participants with new infections is reported.
|
Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2005
Primary Completion (Actual)
October 21, 2010
Study Completion (Actual)
October 21, 2010
Study Registration Dates
First Submitted
May 27, 2008
First Submitted That Met QC Criteria
May 29, 2008
First Posted (Estimate)
May 30, 2008
Study Record Updates
Last Update Posted (Actual)
December 3, 2020
Last Update Submitted That Met QC Criteria
December 2, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Maleic acid
Other Study ID Numbers
- P04100
- MK-7690-027 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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