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The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVG+RTV | Experimental | EVG 85 mg or 150 mg + RTV + ARV regimen Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg. Some participants may receive EVG 300 mg during the course of protocol amendment 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVG | Drug | Elvitegravir (EVG) tablet administered orally once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event | Up to Week 408 plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. | Up to Week 408 plus 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Rhee, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pheonix | Arizona | 85006 | United States | |||
Participants must have been enrolled in other Gilead-sponsored studies of elvitegravir (EVG) + ritonavir (RTV) to be eligible to receive continued access to EVG+RTV in this study.
Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | EVG+RTV | Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RTV | Drug | Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food |
|
|
| ARV regimen | Drug | The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval). |
|
| Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality |
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. |
| Up to Week 408 plus 30 days |
| Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality | A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline. | Up to Week 408 plus 30 days |
| Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
| Incidence of Mortality | The percentage of participants who died was summarized. | Up to Week 408 plus 30 days |
| Little Rock |
| Arkansas |
| 72207 |
| United States |
| Beverly Hills | California | 90211 | United States |
| Costa Mesa | California | 92626 | United States |
| Fountain Valley | California | 92708 | United States |
| Long Beach | California | 90813 | United States |
| Los Angeles | California | 90033 | United States |
| Newport Beach | California | 92663 | United States |
| Palo Alto | California | 94305 | United States |
| San Diego | California | 92103 | United States |
| San Francisco | California | 94110 | United States |
| Norwalk | Connecticut | 06851 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Atlantis | Florida | 33462 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Manors | Florida | 33305 | United States |
| Miami | Florida | 33136 | United States |
| North Miami Beach | Florida | 33169 | United States |
| North Palm Beach | Florida | 33408 | United States |
| Orlando | Florida | 32803 | United States |
| Sarasota | Florida | 34239 | United States |
| Tampa | Florida | 33602 | United States |
| Decatur | Georgia | 30033 | United States |
| Macon | Georgia | 31201 | United States |
| Chicago | Illinois | 60657 | United States |
| Baltimore | Maryland | 21205 | United States |
| Boston | Massachusetts | 02215 | United States |
| West Springfield | Massachusetts | 01107 | United States |
| Saint Louis | Michigan | 63108 | United States |
| Henderson | Nevada | 89074 | United States |
| Hillsborough | New Jersey | 08844 | United States |
| Santa Fe | New Mexico | 87505 | United States |
| Albany | New York | 12208 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10016 | United States |
| Stony Brook | New York | 11794 | United States |
| The Bronx | New York | 11030 | United States |
| Durham | North Carolina | 27110 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Memphis | Tennessee | 38105 | United States |
| Dallas | Texas | 75204 | United States |
| Houston | Texas | 77030 | United States |
| Annandale | Virginia | 22003 | United States |
| Seattle | Washington | 98101 | United States |
| Tacoma | Washington | 98405 | United States |
| Santurce | 00921 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
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| ID | Title | Description |
|---|---|---|
| BG000 | EVG+RTV | EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2. |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event | Safety Analysis Set: enrolled participants who received at least 1 dose of EVG | Posted | Number | percentage of participants | Up to Week 408 plus 30 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. | Safety Analysis Set | Posted | Number | percentage of participants | Up to Week 408 plus 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. | Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed. | Posted | Number | percentage of participants | Up to Week 408 plus 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality | A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline. | Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed. | Posted | Number | percentage of participants | Up to Week 408 plus 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | g/dL | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | 10^6 cells/μL | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | 10^3 cells/μL | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | 10^3 cells/µL | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | U/L | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | U/L | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | U/L | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis. | Posted | Number | percentage of participants | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis. | Posted | Number | percentage of participants | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| ||||||||||||||||||||||||||||
| Secondary | CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | Participants in the Efficacy Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Mortality | The percentage of participants who died was summarized. | Safety Analysis Set | Posted | Number | percentage of participants | Up to Week 408 plus 30 days |
|
|
Baseline through end of study drug treatment (average exposure: 237 weeks) plus 30 days
Safety Analysis Set: enrolled participants who received at least 1 dose of EVG
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 | EVG+RTV | EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2. | 86 | 192 | 172 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Necrotising retinitis | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Serum sickness-like reaction | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Cryptosporidiosis infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| HIV wasting syndrome | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Prostatic abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Sinusitis aspergillus | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paranasal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypogonadism | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@Gilead.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C509700 | elvitegravir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
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| Title | Denominators | Categories | ||||
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