Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC278-TiDP6-C222 | Other Identifier | Janssen R&D Ireland | |
| 2010-021209-18 | EudraCT Number |
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The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 [C204]) or Phase III trials (i.e., TMC278-TiDP6-C209 [C209] or TMC278-TiDP6-C215 [C215]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilpivirine | Experimental | Rilpivirine 25 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine | Drug | 25 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. | Up to 7 years |
| Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality | Number of participants with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of the following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2*baseline value and at least 5 times upper limit of normal; fever greater than (>) 38 degree celsius or 100 degree fahrenheit; eosinophils > 1000/millimeter (mm)^3; serum sickness-like reaction. A grade 4 rash defined as the following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Virologic Rebound | Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (>=) 50 or >=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | Up to Week 360 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
Total of 482 participants were treated and 437 discontinued at data cut-off date (8 February 2018) because they switched to commercially available rilpivirine (RPV) (371 participants), as planned per protocol. Only 6 of the 482 participants discontinued as they reached a virologic endpoint. At last contact date of last participant under Protocol Amendment 3 (28 February 2020), out of 45 participants 37 switched to commercially available RPV and 6 were lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rilpivirine (RPV) (TMC278-C204 [C204]) | Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Main Study) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2016 | Feb 10, 2021 |
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| Time To Treatment Failure | Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA >= 50 or >= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | Up to Week 360 |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach. | Baseline up to weeks 96, 192, 288, 336 |
| Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local [RPV-based] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach). | Baseline up to weeks 96, 192, 288, 336 |
| Number of Participants With Serious Adverse Events (SAEs) | A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect. | Up to 7 years |
| Number of Participants With AEs Related to Rilpivirine (RPV) | Number of participants with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. | Up to 7 years |
| Long Beach |
| California |
| United States |
| Los Angeles | California | United States |
| Newport Beach | California | United States |
| Sacramento | California | United States |
| Washington D.C. | District of Columbia | United States |
| Miami | Florida | United States |
| Miami Beach | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| West Palm Beach | Florida | United States |
| Chicago | Illinois | United States |
| Boston | Massachusetts | United States |
| Springfield | Massachusetts | United States |
| Minneapolis | Minnesota | United States |
| Albany | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| The Bronx | New York | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Portland | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Longview | Texas | United States |
| Seattle | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Buenos Aires | Argentina |
| Ciudad Autonoma Buenos Aires | Argentina |
| Córdoba | Argentina |
| Guernica | Argentina |
| Rosario | Argentina |
| Darlinghurst | Australia |
| Melbourne | Australia |
| Perth | Australia |
| Surry Hills | Australia |
| Victoria | Australia |
| Vienna | Austria |
| Antwerp | Belgium |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Montreal | Canada |
| Santiago | Chile |
| Beijing | China |
| Guangzhou | China |
| Shanghai | China |
| Copenhagen | Denmark |
| Hvidovre | Denmark |
| Odense | Denmark |
| Clamart | France |
| Lyon | France |
| Nantes | France |
| Paris | France |
| Tourcoing | France |
| Berlin | Germany |
| Cologne | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Rotterdam | Netherlands |
| San Juan | Puerto Rico |
| Bucharest | Romania |
| Iași | Romania |
| Kazan' | Russia |
| Krasnodar | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Smolensk | Russia |
| Volgograd | Russia |
| Voronezh | Russia |
| Bloemfontein | South Africa |
| Dundee | South Africa |
| Durban | South Africa |
| Johannesburg | South Africa |
| Johannesburg Gauteng | South Africa |
| Pretoria | South Africa |
| Westdene Johannesburg Gauteng | South Africa |
| Alicante | Spain |
| Barcelona | Spain |
| Elche | Spain |
| Madrid | Spain |
| Stockholm | Sweden |
| Kaohsiung County | Taiwan |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Khon Kaen | Thailand |
| Brighton | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) |
Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC. |
| FG002 | RPV 25 mg (After Protocol Amendment 3) | All Participants who were continued under a simplified study setting with only a minimum of study-related activities, as per Protocol Amendment 3 continued to receive RPV 25 mg and followed up for safety. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 (After Protocol Amendment 3) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rilpivirine (RPV) (TMC278-C204 [C204]) | Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1. |
| BG001 | RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC. |
| BG002 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Time to Virologic Rebound | Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (>=) 50 or >=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens. | Posted | Mean | Standard Error | days | Up to Week 360 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time To Treatment Failure | Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA >= 50 or >= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. | Posted | Mean | Standard Error | days | Up to Week 360 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 | The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach. | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'number of participants analyzed' signifies number of participants analyzed in this outcome measure. Here 'number analyzed' included all participants evaluable at specified timepoint categories. | Posted | Mean | Standard Error | cells/microliter (cells/mcL) | Baseline up to weeks 96, 192, 288, 336 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 | Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local [RPV-based] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach). | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'number of participants analyzed' signifies number of participants analyzed in this outcome measure. Here 'number analyzed' included all participants evaluable at specified timepoint categories. | Posted | Mean | Standard Error | cells/mcL | Baseline up to weeks 96, 192, 288, 336 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect. | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens. | Posted | Number | Participants | Up to 7 years |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. | The intent-to-treat (ITT) population included all participants who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimens. | Posted | Number | Participants | Up to 7 years |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality | Number of participants with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of the following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2*baseline value and at least 5 times upper limit of normal; fever greater than (>) 38 degree celsius or 100 degree fahrenheit; eosinophils > 1000/millimeter (mm)^3; serum sickness-like reaction. A grade 4 rash defined as the following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis. | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens. | Posted | Number | Participants | Up to 7 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With AEs Related to Rilpivirine (RPV) | Number of participants with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. | The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens. | Posted | Number | Participants | Up to 7 years |
|
Up to 7 years
Safety analysis included all participants who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimen.
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 | Rilpivirine (RPV) (TMC278-C204 [C204]) | Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N[t]RTI)s starting Day 1. | 0 | 119 | 9 | 119 | 25 | 119 |
| EG001 | RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215]) | Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC. | 2 | 363 | 16 | 363 | 61 | 363 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cardiac hypertrophy | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Eye infection toxoplasmal | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Lymph node tuberculosis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bone fissure | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
Not all Adverse Events (AEs) were collected; AEs considered related to rilpivirine (RPV), leading to discontinuations, serious adverse events (SAEs), or grade 3/4 events of rash regardless of causality were collected; discontinuation rate was greater than (>) 90 percent which makes interpretation of results difficult.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2018 | Feb 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lost to Follow-up |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Other |
|
| White |
|
| AUSTRALIA |
|
| AUSTRIA |
|
| BELGIUM |
|
| CANADA |
|
| CHILE |
|
| CHINA |
|
| DENMARK |
|
| FRANCE |
|
| GERMANY |
|
| ITALY |
|
| NETHERLANDS |
|
| PUERTO RICO |
|
| ROMANIA |
|
| RUSSIAN FEDERATION |
|
| SOUTH AFRICA |
|
| SPAIN |
|
| SWEDEN |
|
| TAIWAN |
|
| THAILAND |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|