A Phase 2 interventional study of Vicriviroc maleate in HIV and HIV Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-03.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 79 is close to the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants take VCV 30 mg once daily.
Drug: Vicriviroc maleate
VCV 30 mg tablet once daily by mouth.
Also known as: SCH 417690
Percentage of Participants With ≥1 Adverse Events (AEs)
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.
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants Discontinuing Study Therapy Due to AEs
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.
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
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.
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
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.
Time frame: Every 12 months up to 60 months
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
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.
Time frame: Every 12 months up to 60 months
Percentage of Participants With HIV RNA ≥400 Copies/mL
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.
Time frame: Every 12 months up to 60 months
Number of Participants With Coreceptor Tropism Shifts From Baseline
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Up to time of VF in P4100, assessed up to approximately 5.5 years
Number of Participants With AIDS-defining Events (ADEs)
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.
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Number of Participants With New Infections
The number of participants with new infections is reported.
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Participants with human immunodeficiency virus (HIV) infection enrolled in AIDS Clinical Trial Group (ACTG) study A5211 (NCT00082498) and (1) completed the 48-week phase, or (2) had detectable alpha-chemokine receptor 4 (CXCR4)-tropic virus but maintained a virologic response and no drop in cluster of differentiation 4 (CD4)/CD8 count from baseline, or (3) met all inclusion/exclusion criteria but were unable to enroll in ACTG A5211 due to protocol closure prior to their randomization and dosing.
| Milestone | VCV 30 mg |
|---|---|
| Started | 79 |
| Completed | 0 |
| Not completed | 79 |
| Withdrew: Adverse event | 5 |
| Withdrew: Lack of efficacy | 6 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 14 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Sponsor discontinued vcv | 47 |
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.
| Percentage of Participants | VCV 30 mg |
|---|---|
| Percentage of Participants With ≥1 Adverse Events (AEs) | 91 |
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.
| Percentage of Participants | VCV 30 mg |
|---|---|
| Percentage of Participants Discontinuing Study Therapy Due to AEs | 6 |
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.
| Percentage of Participants | VCV 30 mg |
|---|---|
| Percentage of Participants With ≥1 Serious Adverse Events (SAEs) | 48 |
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.
| Percentage of Participants | VCV 30 mg |
|---|---|
| Month 12 | 52 |
| Month 24 | 64 |
| Month 36 | 80 |
| Month 48 | 89 |
| Month 60 | 80 |
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.
| Percentage of Participants | VCV 30 mg |
|---|---|
| Month 12 | 13 |
| Month 24 | 11 |
| Month 36 | 12 |
| Month 48 | 2 |
| Month 60 | 15 |
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.
| Percentage of Participants | VCV 30 mg |
|---|---|
| Month 12 | 35 |
| Month 24 | 25 |
| Month 36 | 8 |
| Month 48 | 9 |
| Month 60 | 5 |
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.
| Participants | VCV 30 mg |
|---|---|
| NR Baseline to NR VF | 45 |
| NR at Baseline to R5 VF | 10 |
| NR Baseline to DM/X4 VF | 5 |
| R5 baseline to R5 VF | 11 |
| R5 baseline to NR VF | 3 |
| R5 baseline to DM/X4 VF | 1 |
| DM/X4 baseline to DM/X4 VF | 3 |
| DM/X4 baseline to R5 VF | 1 |
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.
| cells/mm^3 | VCV 30 mg |
|---|---|
| Month 2 | -16.26 ± 103.83 |
| Month 4 | -17.70 ± 84.87 |
| Month 6 | 9.30 ± 95.38 |
| Month 8 | -0.20 ± 115.96 |
| Month 10 | 12.59 ± 97.84 |
| Month 12 | -13.81 ± 124.09 |
| Month 14 | 18.56 ± 106.18 |
| Month 16 | 21.63 ± 130.33 |
| Month 18 | 2.82 ± 108.52 |
| Month 20 | 19.71 ± 125.34 |
| Month 22 | 24.19 ± 94.37 |
| Month 24 | 32.04 ± 121.45 |
| Month 26 | 34.36 ± 128.99 |
| Month 28 | 36.10 ± 120.75 |
| Month 30 | 38.10 ± 113.80 |
| Month 32 | 47.59 ± 137.15 |
| Month 34 | 61.93 ± 109.71 |
| Month 36 | 43.63 ± 136.85 |
| Month 38 | 90.81 ± 140.11 |
| Month 40 | 75.53 ± 142.90 |
| Month 42 | 104.65 ± 187.14 |
| Month 44 | 91.61 ± 181.71 |
| Month 46 | 91.19 ± 165.33 |
| Month 48 | 93.93 ± 174.36 |
| Month 50 | 128.12 ± 189.94 |
| Month 52 | 107.41 ± 170.97 |
| Month 54 | 136.00 ± 211.98 |
| Month 56 | 129.87 ± 196.80 |
| Month 58 | 188.81 ± 152.93 |
| Month 60 | 122.60 ± 191.32 |
| Month 62 | 132.54 ± 118.87 |
| Month 64 | 147.50 ± 197.12 |
| Month 66 | 283.50 ± 2.12 |
| Month 68 | 300.00 ± 50.91 |
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.
| Participants | VCV 30 mg |
|---|---|
| Number of Participants With Reduced Susceptibility to VCV | 7 |
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.
| Participants | VCV 30 mg |
|---|---|
| Plasmablastic Lymphoma | 1 |
| Kaposi's Sarcoma | 1 |
The number of participants with new infections is reported.
| Participants | VCV 30 mg |
|---|---|
| Herpes simplex virus infection | 6 |
| Upper respiratory tract infection | 39 |
Collected over Up to approximately 5.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VCV 30 mg | 3/79 (3.8%) | 38/79 (48.1%) | 70/79 (88.6%) |
| Event | VCV 30 mg |
|---|---|
| PNEUMONIAInfections and infestations | 5/79 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 5/79 |
| CARDIAC FAILURE CONGESTIVECardiac disorders | 3/79 |
| CHEST PAINGeneral disorders | 3/79 |
| PYREXIAGeneral disorders | 3/79 |
| CELLULITISInfections and infestations | 3/79 |
| BLOOD AMYLASE INCREASEDInvestigations | 3/79 |
| DIARRHOEAGastrointestinal disorders | 2/79 |
| NAUSEAGastrointestinal disorders | 2/79 |
| VOMITINGGastrointestinal disorders | 2/79 |
| Event | VCV 30 mg |
|---|---|
| FATIGUEGeneral disorders | 29/79 |
| NAUSEAGastrointestinal disorders | 28/79 |
| DIARRHOEAGastrointestinal disorders | 26/79 |
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 25/79 |
| COUGHRespiratory, thoracic and mediastinal disorders | 23/79 |
| HEADACHENervous system disorders | 20/79 |
| PYREXIAGeneral disorders | 18/79 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 18/79 |
| DIZZINESSNervous system disorders | 16/79 |
| SINUSITISInfections and infestations | 15/79 |
| Age, Continuous(Years) | VCV 30 mg |
|---|---|
| Mean | 49 (30 to 67) |
| Sex: Female, Male(Participants) | VCV 30 mg |
|---|---|
| Female | 5 |
| Male | 74 |
| Race (NIH/OMB)(Participants) | VCV 30 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 60 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Merck Sharp & Dohme LLC