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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7690-027 | Other Identifier | Merck Protocol Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCV 30 mg | Experimental | Participants take VCV 30 mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicriviroc maleate | Drug | VCV 30 mg tablet once daily by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20672447 | Result | 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. | |
| 20400411 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | VCV 30 mg | Participants took VCV 30 mg once daily. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | 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. | 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. | 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. | 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. | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) |
| 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. |
| 19191652 | Result | 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. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VCV 30 mg | Participants took VCV 30 mg once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All treated participants are included. | Posted | Number | Percentage of Participants | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | 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. | All treated participants are included. | Posted | Number | Percentage of Participants | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants are included. | Posted | Number | Percentage of Participants | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants with HIV RNA data available are included. | Posted | Number | Percentage of Participants | Every 12 months up to 60 months |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants with HIV RNA data available are included. | Posted | Number | Percentage of Participants | Every 12 months up to 60 months |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants with HIV RNA data available are included. | Posted | Number | Percentage of Participants | Every 12 months up to 60 months |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants with baseline and VF tropism data available are included. | Posted | Number | Participants | Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants with baseline and on-treatment CD4/CD8 data available are included. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years |
|
| ||||||||||||||||||||||||||
| Primary | 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. | All treated participants are included. | Posted | Number | Participants | Up to time of VF in P4100, assessed up to approximately 5.5 years |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All treated participants are included. | Posted | Number | Participants | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With New Infections | The number of participants with new infections is reported. | All treated participants are included. | Posted | Number | Participants | Up to discontinuation of commercial VCV availability (up to approximately 5.5 years) |
|
|
Up to approximately 5.5 years
All treated participants are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VCV 30 mg | Participants took VCV 30 mg once daily. | 3 | 79 | 38 | 79 | 70 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OPTIC ISCHAEMIC NEUROPATHY | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OESOPHAGEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PARAESTHESIA ORAL | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RETROPERITONEAL HAEMATOMA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SWOLLEN TONGUE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ALLERGY TO VACCINE | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANOGENITAL WARTS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| ENDOCARDITIS BACTERIAL | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| MENINGITIS COCCIDIOIDES | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| VIRAL PERICARDITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| BLOOD AMYLASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| AXILLARY MASS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| METASTATIC SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MUSCLE CONTRACTIONS INVOLUNTARY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIAC PACEMAKER REVISION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| COLOSTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| HYSTERECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| LAMINAPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| LARGE INTESTINE ANASTOMOSIS | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| OESOPHAGOGASTRIC FUNDOPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SIGMOIDECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| EMBOLISM ARTERIAL | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EAR CONGESTION | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| EYE PRURITUS | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| BLOOD AMYLASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SINUS OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (1) proprietary information that is protected by the provisions contained in paragraph B below, (2) the accuracy of the information contained in the publication, and (3) to ensure that the presentation is fairly balanced and in compliance with FDA regulations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C486781 | vicriviroc |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Herpes simplex virus infection |
| |||||
| Upper respiratory tract infection |
|