Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0518-138 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiretroviral combination therapy including raltegravir | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir was administered in combination with ARV therapies at the discretion of the investigator in accordance with the product label. The recommended dose of raltegravir is 400 mg twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others. | Up to 25 months after start of raltegravir treatment |
| Percentage of Participants Responding to Treatment: All Treated Participants | Response to treatment was defined as a viral load <50 RNA copies/mL | 24 months after start of raltegravir treatment |
| Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | Response to treatment was defined as a viral load <50 RNA copies/mL | 24 months after start of raltegravir treatment |
| Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | Baseline and 24 months after start of raltegravir treatment | |
| Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | Baseline and 24 months after start of raltegravir treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adverse Event | An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product. | Up to 25 months after start of raltegravir treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participant Infected With HIV-1
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Of 482 participants included in the trial, 2 were excluded from analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
| FG001 | Suppressed at Baseline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ARV (non-raltegravir) | Drug | ARV treatments were administered in combination with raltegravir at the discretion of the investigator in accordance with the product labels, and could include nucleoside reverse-transcriptase inhibitor, non-nucleoside reverse-transcriptase inhibitor, protease inhibitor, entry inhibitor, and integrase inhibitor catagories. |
|
Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
| FG002 | Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ARV naïve at Baseline | ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
| BG001 | Suppressed at Baseline | Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met). |
| BG002 | Virological Failure at Baseline | Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis | Mean | Standard Deviation | Years |
|
| 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 Receiving Antiretroviral Treatments Administered With Raltegravir | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others. | Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants. | Posted | Number | Percentage of participants | Up to 25 months after start of raltegravir treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Responding to Treatment: All Treated Participants | Response to treatment was defined as a viral load <50 RNA copies/mL | All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 months after start of raltegravir treatment |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 | Response to treatment was defined as a viral load <50 RNA copies/mL | All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 months after start of raltegravir treatment |
| |||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants | All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline and 24 months after start of raltegravir treatment |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 | All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline and 24 months after start of raltegravir treatment |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One Adverse Event | An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product. | Participants enrolled and not excluded for a protocol violation were included in the analysis. | Posted | Number | Participants | Up to 25 months after start of raltegravir treatment |
|
|
Not provided
Two participants were excluded from the analysis because of protocol violation (inclusion criterion not met).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antiretroviral Combination Therapy Including Raltegravir | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. | 66 | 480 | 27 | 480 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC DISORDER | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEAFNESS | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIARRHOEA HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INGUINAL HERNIA STRANGULATED | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SWELLING | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CRYOGLOBULINAEMIA | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| IMMUNE RECONSTITUTION SYNDROME | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ABSCESS NECK | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CANDIDA SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBRAL TOXOPLASMOSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS CHORIORETINITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| HISTOPLASMOSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| HISTOPLASMOSIS DISSEMINATED | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| MENINGITIS VIRAL | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| MYCOBACTERIAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECI PNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| ACCIDENT | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| DEVICE FAILURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| POST-TRAUMATIC PAIN | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| SCAN | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MITOCHONDRIAL CYTOPATHY | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OSTEOPENIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CARCINOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| OROPHARYNGEAL CANCER STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LIBIDO DECREASED | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NEGATIVE THOUGHTS | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PARANOIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SCHIZOPHRENIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GYNAECOMASTIA | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HYPERCAPNIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LIPODYSTROPHY ACQUIRED | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| BENIGN TUMOUR EXCISION | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| DENTAL OPERATION | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| HERNIA REPAIR | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| INGUINAL HERNIA REPAIR | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| LEG AMPUTATION | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| PHLEBOTOMY | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| PULMONARY VALVE REPLACEMENT | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
Not provided
Not provided
| 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 |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Title | Measurements |
|---|---|
|
| Mulitple (>=3 ) ARV therapies + raltegravir |
|
| Protease inhibitor + raltegravir |
|
| Other strategies (each <5%) |
|
Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
| OG003 | All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
|
|
Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
| OG003 | All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
|
|
| OG003 | All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
|
|
| OG003 | All Participants | Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. |
|
|
|