Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC125-C229 | Other Identifier | Tibotec Pharmaceuticals, Ireland |
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
Not provided
The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.
This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another clinical study). Participants who were randomized (study medication is assigned by chance) to a etravirine (ETR) treatment arm in Phase II TMC125 feeder studies (TMC125-C203, TMC125-C209, TMC125-C223 and TMC125-C211), were treated for at least 48 weeks with etravirine, and who will derive continued benefit from etravirine therapy, as judged by the investigator, will be enrolled in this study. The final visit of the sponsor-selected Phase II ETR study will be the first (baseline) visit of this study. Approximately 300 participants will be enrolled in this study who will receive 800 mg twice daily of etravirine (formulation TF035) until the formulation 200 mg twice daily (formulation F060) is available. Once this formulation becomes available all the participants will be switched to receive F060 which will be given in combination with an investigator-selected, optimized underlying therapy (nucleotide reverse transcriptase [NRTIs] and/or allowed protease inhibitors and/or enfuvirtide). Participants will continue to receive ETR until they are no longer benefitted or this medication becomes commercially available. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etravirine + 2 antiretrovirals | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etravirine (ETR) | Drug | Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants who reported at least 1 of the adverse events. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48 | Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tibotec Pharmaceuticals, Ireland Clinical Trial | Tibotec Pharmaceuticals, Ireland | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| TMC125-C229: TMC125 in HIV-1 Infected Subjects, Who Were Randomized to a TMC125 Treatment Arm in a Sponsor Selected TMC125 Trial and Were Treated for at Least 48 Weeks | View source |
Not provided
In total, 211 participants (93 who rolled over from the etravirine arm of study TMC125-C203 (NCT00412646), 85 who rolled over from the etravirine arm of study TMC125-C223 (NCT00081978), 29 who rolled over from study TMC125-C211 (NCT00111280) and 4 who rolled over from study TMC125-C209) received treatment with etravirine.
In this study, 211 participants were enrolled in 12 different countries. The majority of participants (49%) were enrolled in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etravirine | 800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Nucleotide reverse transcriptase inhibitors (NRTIs) | Drug | Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). |
|
| Protease inhibitors (PIs) | Drug | Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). |
|
| Enfuvirtide (ENF) | Drug | Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). |
|
| Week 48 |
| Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96 | Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Week 96 |
| Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Week 96 |
| Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Week 192 |
| Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48 | The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Week 48 |
| Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96 | The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Week 96 |
| Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Week 96 |
| Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Week 192 |
| Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation) | Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant). | Baseline and Endpoint (ie, the last available time point during the treatment period) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etravirine | 800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48 | Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48 | Posted | Number | Participants | Week 48 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96 | Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96 | Posted | Number | Participants | Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96 | Posted | Number | Participants | Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192 | Posted | Number | Participants | Week 192 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48 | The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48 | Posted | Median | Full Range | x 100000 cells/L | Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96 | The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline. | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96 | Posted | Median | Full Range | x 1000000 cells/L | Week 96 |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96 | Posted | Median | Full Range | x 1000000 cells/mL | Week 96 |
|
| |||||||||||||||||||||||||||||
| Secondary | Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192 | Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies). | Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192 | Posted | Median | Full Range | x 1000000 cells/mL | Week 192 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation) | Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant). | Intent-to-treat population: Participants who received at least 1 dose of study medication were included | Posted | Number | Participants | Baseline and Endpoint (ie, the last available time point during the treatment period) |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events | Number of participants who reported at least 1 of the adverse events. | Intent-to-treat population: Participants who received at least 1 dose of study medication were included | Posted | Number | Participants | Up to 3 years |
|
|
Up to 3 years
Not provided
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 | Etravirine | 800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060) | 46 | 211 | 147 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fanconi syndrome | Congenital, familial and genetic disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Histoplasmosis disseminated | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumocystis jiroveCI pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Biopsy kidney | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Biopsy liver | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diabetes mellitus non-insulin-dependent | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Gum neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
| |
| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominoplasty | Surgical and medical procedures | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 9.1 | Non-systematic Assessment |
| |
| Wound treatment | Surgical and medical procedures | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Physician | Tibotec Pharmaceuticals | +32-14-607-767 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C451734 | etravirine |
| D011480 | Protease Inhibitors |
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| White |
|
| Hispanic |
|
| Other |
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|