| ID | Type | Description | Link |
|---|---|---|---|
| TMC114IFD3001 | Other Identifier | Janssen Sciences Ireland UC | |
| 2017-000285-30 | EudraCT Number |
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The primary objective of this trial is to continue the provision of darunavir/ low-dose ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of darunavir in combination with low-dose ritonavir (DRV/rtv), in countries where DRV is not commercially available for the subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program) and to provide DRV through this trial until the participants can switched to locally available DRV-based treatment regimens (that is commercially available and reimbursed, or accessible through another source [for example, access program or government program]) or to local standard of care, as appropriate.
This is a continued access trial for adult and pediatric patients who have completed treatment with darunavir in combination with low-dose ritonavir (DRV/rtv) in the parent clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the parent pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of DRV/rtv, and who live in a country where DRV is not accessible. At the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility. Once the eligibility criteria are met, patients will continue treatment as follows: HIV-1-infected patients participating in the TMC114-C211 trial and some HIV-1 infected patients from the pediatric trial TMC114-TiDP29-C232 will continue on the selected DRV/rtv once daily dosing regimen as administered in the original trial, or (for pediatric patients) on an adjusted dose if necessary due to a change in body weight. Some HIV-infected patients from the pediatric trial TMC114-TiDP29-C232 will continue on the selected twice daily DRV/rtv dosing regimen as administered in the original trial, or (for pediatric patients) on an adjusted dose if necessary due to a change in body weight. HIV-1-infected patients having participated in the TMC114-C214 or TMC114-TiDP31-C229 trial will continue on the DRV/rtv 600/100 mg twice daily dosing regimen as administered in the original trial. Visits and assessment are performed according to local standard of care, but desirable every 3 months for pediatric patients and not less frequently than every 6 months for adult patients. The interval between 2 consecutive visits should not exceed 6 months for pediatric patients. Adverse events (AEs) considered at least possibly related to DRV/rtv, AEs leading to discontinuation or treatment interruption, serious AEs (SAEs), and pregnancies (or all AEs if applicable per local regulation) will be recorded at each visit. Patients will be instructed to report any AEs to the investigator, who will report SAEs within 24 hours to the Sponsor. In addition to the assessments in the flowchart, the following assessments are recommended to be performed locally every 3 months or according to local, generally accepted standards of care: efficacy assessments (immunology and plasma viral load) and laboratory safety assessments (hematology and biochemistry, including pancreatic amylase [if available] or lipase and lipid analyses). Treatment will be continued until one of the following criteria is met (whichever occurs first): virologic failure; treatment-limiting toxicity; loss to follow-up; withdrawal of consent/assent by the patient; withdrawal of consent by the parent(s)/legal representative(s); pregnancy; termination of the trial by the sponsor; DRV based treatment regimen becomes commercially available for the patients and is reimbursed, or can be accessed through another source (for example, access program, government program) in the region the patient is living in or patients can be switched to local standard of care, as appropriate. A post-treatment follow-up contact is to be performed 4 weeks after the last dose of trial medication for patients with an ongoing adverse event, that discontinue the trial. This is consistent with the primary objective of the study to provide continued access to DRV/rtv for adult patients who previously received DR/rtv in the clinical trials sponsored by Tibotec Pharmaceuticals. This study is not set up to address any specific hypothesis. Depending on the previous trial the patients were in, they will continue to take either : DRV/rtv 800/100 mg once a day as 2 tablets of 400 mg DRV and 100 mg ritonavir; or DRV/rtv 600/100 mg twice a day as 1 tablet of 600 mg DRV and 100 mg ritonavir twice a day; DRV/rtv 375/100 mg twice a day as 1 tablet of 375 mg DRV and 100 mg ritonavir; DRV/rtv selected dose twice daily , or on an adjusted dose if necessary due to a change in body weight. For most of the patients, their next visit will be the final visit with data collection thereafter visits and assessments will be performed per local standard of care and documented in the patient's medical records only. Investigators will continue to report serious adverse events (SAEs) possibly related to DRV/rtv and pregnancies to the sponsor using regular reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued Treatment with DRV in Combination with rtv | Experimental | HIV-1 infected children participants (aged less than [<] 12 years) will continue to receive darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID. HIV-1 infected adolescent participants (aged 12-17 years) will continue to receive DRV 200 to 600 mg as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID. Dosing for children and adolescent participants will be based on body weight (per parent study TMC114-TiDP29-C232). HIV-1 infected adult participants (aged greater than or equal to [>=] 18 years) will continue to receive DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally BID along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir | Drug | Participants will receive darunavir (per parent study) as oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | Adverse events (AEs): any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a participant administered a pharmaceutical product and which did not necessarily have causal relationship with study treatment. Serious adverse events (SAEs): any untoward medical occurrence at any dose resulted: death; was life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity or congenital anomaly/birth defect. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses. | Up to 9 years 11 months |
| Number of Participants With Adverse Events Leading to Study Drug Discontinuation | Adverse events (AEs) were defined as any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses. | Up to 9 years 11 months |
| Number of Participants With Adverse Events Possibly Related to Darunavir/Ritonavir (DRV/Rtv) Treatment | Number of participants with adverse events possibly related to DRV/rtv treatment were reported. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses. |
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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 |
|---|---|---|---|---|---|---|
| Rio de Janeiro | Brazil | |||||
Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies (TMC114-C211,TMC114-C214 or TMC114-TiDP31-C229). Main purpose of this study was to provide continued access and not to compare the 2 doses (DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily).
Participants who had completed treatment with darunavir/ritonavir (DRV/rtv) in the adult clinical (parent) trials TMC114-C211 (NCT00258557), TMC114-C214 (NCT00110877), TMC114-TiDP31-C229 (NCT00524368) or in the pediatric (parent) trial TMC114-TiDP29-C232 (NCT01138605), who continued to benefit from the use of DRV/rtv, and who lived in a country where DRV was not accessible participated in this trial and continued treatment as per their respective parent study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years | HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months). |
| 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 | Jun 20, 2019 | Jun 29, 2022 |
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| Ritonavir | Drug | Participants will receive ritonavir (per parent study) as oral solution/suspension. |
|
| Up to 9 years 11 months |
| San José |
| Costa Rica |
| Guatemala City | Guatemala |
| Kuala Selangor | Malaysia |
| Panama City | Panama |
| Cape Town | South Africa |
| Cyrildene Johannesburg Gauteng | South Africa |
| Dundee | South Africa |
| Durban | South Africa |
| Johannesburg | South Africa |
| Pretoria | South Africa |
| Soweto | South Africa |
| Westdene Johannesburg Gauteng | South Africa |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Khon Kaen | Thailand |
| Vinnitsa | Ukraine |
| FG001 | Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years) | HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months). |
| FG002 | Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years) | HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years | HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months). |
| BG001 | Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years) | HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months). |
| BG002 | Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years) | HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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 Serious Adverse Events | Adverse events (AEs): any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a participant administered a pharmaceutical product and which did not necessarily have causal relationship with study treatment. Serious adverse events (SAEs): any untoward medical occurrence at any dose resulted: death; was life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity or congenital anomaly/birth defect. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses. | Full Analysis Set (FAS) included all participants who had taken at least one dose of Darunavir (DRV), regardless of their compliance with the protocol and adherence to the dose regimen. | Posted | Count of Participants | Participants | Up to 9 years 11 months |
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| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events Leading to Study Drug Discontinuation | Adverse events (AEs) were defined as any untoward medical occurrence (any unfavorable and unintended sign [including an abnormal laboratory finding], symptom, or disease) that occurred in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses. | FAS included all participants who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen. | Posted | Count of Participants | Participants | Up to 9 years 11 months |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events Possibly Related to Darunavir/Ritonavir (DRV/Rtv) Treatment | Number of participants with adverse events possibly related to DRV/rtv treatment were reported. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses. | FAS included all participants who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen. | Posted | Count of Participants | Participants | Up to 9 years 11 months |
|
Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
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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 | Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years | HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months). | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years) | HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months). | 0 | 4 | 1 | 4 | 0 | 4 |
| EG002 | Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years) | HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months). | 3 | 137 | 26 | 137 | 4 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Deafness Unilateral | Ear and labyrinth disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bone Tuberculosis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Breast Abscess | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Groin Abscess | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Infected Cyst | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Foetal Exposure During Pregnancy | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Maternal Exposure During Breast Feeding | 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 |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Hodgkin's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | 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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| Abortion Threatened | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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| Foetal Death | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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| Premature Baby | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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| Premature Labour | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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| Acute Psychosis | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Intentional Self-Injury | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Immature Respiratory System | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Development | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2022 | Jun 29, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
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| Male |
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| Asian |
|
| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hispanic |
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| Other |
|
| COSTA RICA |
|
| GUATEMALA |
|
| MALAYSIA |
|
| PANAMA |
|
| SOUTH AFRICA |
|
| THAILAND |
|
| UKRAINE |
|
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months). |
| OG002 | Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years) | HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months). |
|
|
| OG002 | Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years) | HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months). |
|
|