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| ID | Type | Description | Link |
|---|---|---|---|
| TMC125-TIDP35-C239 | Other Identifier | Janssen Research & Development, LLC | |
| 2009-013126-16 | EudraCT Number |
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The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source [example, access program or government program]), or local standard of care, as appropriate.
This is open label continued access trial for HIV-1 infected children/adolescents who have completed treatment in clinical (parent) trial with etravirine (ETR) sponsored by/in collaboration with Janssen Research & Development and who continue to benefit from use of ETR. At baseline visit, eligibility criteria will be checked. If eligibility criteria are met, participants will either continue on ETR dose they received in previous ETR (parent) trial or on adjusted dose if required by investigator.ETR dose adjustment will be based on weight using dosing guidelines. Assessment visits are recommended every 3 months (pediatric) and 6 months (adults). For most of participant, their next visit will be final visit with data collection. New participants entering study, will have baseline visit without data collection. Thereafter visits and assessments will be performed per local standard of care and documented in the participant's medical records only. Investigators will continue to report SAEs possibly related to ETR and pregnancies to sponsor using regular reporting. Treatment will be continued until: investigator determines that participant no longer benefits from ETR treatment (e.g based on viral load); treatment limiting toxicity; loss to follow-up; consent withdrawal; pregnancy; program termination by Sponsor; ETR-based treatment regimen becomes commercially available for participant's use, and is reimbursed, or accessed by another source (e.g access/government program) in region participant is living, or participants switched to local standard of care, as appropriate. Adult participants will receive ETR 200mg BID.Pediatric participants will receive ETR, doses as received in previous ETR(parent) trial, with weight based dose adjustment if necessary.
10 to <20kg:100mg BID (4*25mg or 1 tablet 100mg) 20 to <25kg:125mg BID (5*25mg or 1 tablet 100mg+1 tablet 25mg) 25 to <30kg:150mg BID (6*25mg or 1 tablet 100mg+2 tablets 25mg) >= 30kg:200mg BID (8*25mg or 2*100mg)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etravirine | Experimental | Etravirine Dosed by weight up to a maximum dose of 200 milligram (mg) bid until switched to an etravirine (ETR)-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etravirine | Drug | Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 10 years and 11 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Etravirine | Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall 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 | Jul 22, 2019 | Nov 24, 2021 |
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| Washington D.C. |
| District of Columbia |
| United States |
| New York | New York | United States |
| Philadelphia | Pennsylvania | United States |
| Buenos Aires | Argentina |
| Ciudad Autonoma de Buenos Aire | Argentina |
| Belo Horizonte | Brazil |
| Ribeirão Preto | Brazil |
| Rio de Janeiro | Brazil |
| Montreal | Quebec | Canada |
| Lyon | France |
| Paris | France |
| Panama City | Panama |
| Rio Piedras | Puerto Rico |
| Bucharest | Romania |
| Bloemfontein | South Africa |
| Boksburg | South Africa |
| Cape Town | South Africa |
| Dundee | South Africa |
| Durban | South Africa |
| George | South Africa |
| Johannesburg | South Africa |
| Newtown | South Africa |
| Pretoria | South Africa |
| Esplugues de Llobregat | Spain |
| Madrid | Spain |
| Seville | Spain |
| Bangkok | Thailand |
| Khon Kaen | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etravirine | Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| AgeContinuous | Mean | Standard Deviation | years |
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| 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 | Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Safety analysis set included all participants who received at least one dose of etravirine. | Posted | Count of Participants | Participants | Up to 10 years and 11 months |
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Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etravirine | Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research & Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than [<] 20 kilograms [kg]; ETR 125 mg bid for weight 20 to <25 kg; ETR 150 mg bid for weight 25 to <30 kg; and 200 mg bid for weight greater than or equal to [>=] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use. | 6 | 180 | 18 | 180 | 32 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Accidental Death | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Chronic Tonsillitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Disseminated Tuberculosis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Brain Herniation | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Melanoma Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Metastases to Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Metastases to Lymph Nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hypovolaemic Shock | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Mitral Valve Incompetence | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Aphthous Ulcer | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Herpes Simplex | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Lice Infestation | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Otitis Media | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Vulvovaginal Candidiasis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hepatic Enzyme Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Lipase Increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nephropathy | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Amenorrhoea | Reproductive system and breast disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Prurigo | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the pre-publication manuscript prior to submission of the manuscript to the publisher, as specified in the Clinical Trial Agreement between Institution/Investigator and Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DIRECTOR CLINICAL LEADER EST PRODUCTS | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2021 | Nov 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C451734 | etravirine |
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| >=65 years |
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| CANADA |
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| FRANCE |
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| ITALY |
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| PANAMA |
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| ROMANIA |
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| SOUTH AFRICA |
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| SPAIN |
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| THAILAND |
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| UNITED STATES |
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