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| Name | Class |
|---|---|
| MUC Research GmbH | OTHER |
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This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants who received JULUCA | Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir [DTG] / Rilpivirine [RPV]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JULUCA | Drug | JULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Virologic Suppression at Year 3 | Virologic suppression (VS) was defined as HIV-RNA less than (<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (>=)200 c/mL. | At Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2 | VS was defined as HIV-RNA <50 c/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA >=200 c/mL. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Two hundred treatment experienced and virologically suppressed HIV positive participants were included in this study. The participants were included at the discretion of the treating physician based on the local summary of product characteristics (SmPC) of JULUCA.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aachen | 52062 | Germany | |||
| GSK Investigational Site |
Not provided
Not provided
Not provided
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Not provided
A total of 209 participants were enrolled in the full analysis set (FAS) from which 9 participants were excluded due to not meeting the eligibility criteria. Therefore, 200 participants formed the modified FAS (mFAS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Who Received JULUCA | Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir [DTG] / Rilpivirine [RPV]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2020 | May 13, 2024 |
Not provided
Not provided
Not provided
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| At Year 1 and Year 2 |
| Number of Participants With Low Level Viremia | Low level viremia was defined as a VL greater than (>) 50 to <200 c/mL. | At Year 1, Year 2 and Year 3 |
| Number of Participants With Virologic Rebound | Virologic rebound was defined as two consecutive VL measurements of >=200 c/mL. | At Year 1, Year 2 and Year 3 |
| Number of Participants With Treatment Switch | The treatment switch could have been due to virologic failure (VF) or due to intolerability and last observation carried forward (LOCF) as determined at the discretion of the physician. | At Year 1, Year 2 and Year 3 |
| Number of Monitoring Measures During the 3-year Follow-up | The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years. | Up to Year 3 |
| Number of Participants With Serious Adverse Events (SAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product. A SAEs was defined as any adverse event meeting the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital anomaly in the off-spring of a participant, was medically significant or could have required intervention to prevent the previously stated outcomes. | Up to Year 3 |
| Number of Participants With Adverse Drug Reactions (ADRs) | An ADR was defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility (i.e. the relationship) cannot be ruled out. | Up to Year 3 |
| Number of Participants With Adherence to Therapy | Adherence to therapy refers to the missed monthly doses. At each follow-up visit, participants were asked to give an estimation of their level of adherence to their antiretroviral therapy (ART). | At Year 1, Year 2 and Year 3 |
| Change From Baseline (BL) in Lipid Laboratory Values | To assess the impact on the lipid metabolism, changes in the following parameters were analyzed: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides. | At Year 1, Year 2 and Year 3 |
| Change in Treatment Satisfaction | The change in HIV treatment satisfaction was assessed with the help of the HIV Treatment Satisfaction questionnaire (HIVTSQs), which is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc. HIV TSQs total score: unweighted sum of 10 items of the HIV TSQs (range: 0-60; with higher scores indicating greater treatment satisfaction). | At Year 1, Year 2 and Year 3 |
| Change in Symptom Distress | The change in HIV symptom distress was assessed with the help of the HIV Symptom Distress Module (SDM); which is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. SDM total score: unweighted sum of the 20 items (using a 5-point scale, ranging from 0-4), ranging from 0 to 80. Higher scores indicate higher degrees of symptom distress. | At Year 1, Year 2 and Year 3 |
| Number of Participants by Reasons for Therapy Switch to JULUCA | The primary and secondary reasons for therapy switch were presented. | At Baseline (Day 1) |
| Berlin |
| 10117 |
| Germany |
| GSK Investigational Site | Berlin | 10243 | Germany |
| GSK Investigational Site | Berlin | 10629 | Germany |
| GSK Investigational Site | Berlin | 12163 | Germany |
| GSK Investigational Site | Berlin | 14057 | Germany |
| GSK Investigational Site | Berlin | 14059 | Germany |
| GSK Investigational Site | Bochum | 44787 | Germany |
| GSK Investigational Site | Chemnitz | 09111 | Germany |
| GSK Investigational Site | Cologne | 50668 | Germany |
| GSK Investigational Site | Cologne | 50674 | Germany |
| GSK Investigational Site | Essen | 45122 | Germany |
| GSK Investigational Site | Hamburg | 20146 | Germany |
| GSK Investigational Site | Hamburg | 20246 | Germany |
| GSK Investigational Site | München | 80331 | Germany |
| GSK Investigational Site | München | 80335 | Germany |
| GSK Investigational Site | München | 80336 | Germany |
| GSK Investigational Site | München | 80801 | Germany |
| GSK Investigational Site | München | 81675 | Germany |
| GSK Investigational Site | Münster | 48143 | Germany |
| GSK Investigational Site | Osnabrück | 49090 | Germany |
| GSK Investigational Site | Tübingen | 72076 | Germany |
| GSK Investigational Site | Weimar | 99427 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants Who Received JULUCA | Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir [DTG] / Rilpivirine [RPV]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||||
| Age, Customized | 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 |
|
| 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 Sustained Virologic Suppression at Year 3 | Virologic suppression (VS) was defined as HIV-RNA less than (<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (>=)200 c/mL. | The analysis was performed on the modified Full Analysis Set (mFAS) which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Count of Participants | Participants | At Year 3 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2 | VS was defined as HIV-RNA <50 c/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA >=200 c/mL. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Count of Participants | Participants | At Year 1 and Year 2 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Low Level Viremia | Low level viremia was defined as a VL greater than (>) 50 to <200 c/mL. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Count of Participants | Participants | At Year 1, Year 2 and Year 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Virologic Rebound | Virologic rebound was defined as two consecutive VL measurements of >=200 c/mL. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Count of Participants | Participants | At Year 1, Year 2 and Year 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Switch | The treatment switch could have been due to virologic failure (VF) or due to intolerability and last observation carried forward (LOCF) as determined at the discretion of the physician. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Count of Participants | Participants | At Year 1, Year 2 and Year 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Monitoring Measures During the 3-year Follow-up | The HIV monitoring measures included were defined as HIV-RNA measurements, normalized to participant years. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Median | Inter-Quartile Range | Measurements per year | Up to Year 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational product, whether or not related to the medicinal investigational product. A SAEs was defined as any adverse event meeting the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a congenital anomaly in the off-spring of a participant, was medically significant or could have required intervention to prevent the previously stated outcomes. | The analysis was performed on the safety analysis set (SAS) which included all participants who received at least one dose of DTG+RPV. | Posted | Count of Participants | Participants | Up to Year 3 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Drug Reactions (ADRs) | An ADR was defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility (i.e. the relationship) cannot be ruled out. | The analysis was performed on the SAS which included all participants who received at least one dose of DTG+RPV. | Posted | Count of Participants | Participants | Up to Year 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adherence to Therapy | Adherence to therapy refers to the missed monthly doses. At each follow-up visit, participants were asked to give an estimation of their level of adherence to their antiretroviral therapy (ART). | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the self-assessment questionnaire of adherence. | Posted | Count of Participants | Participants | At Year 1, Year 2 and Year 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (BL) in Lipid Laboratory Values | To assess the impact on the lipid metabolism, changes in the following parameters were analyzed: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who had laboratory parameters data at baseline and at years 1, 2 or 3. | Posted | Median | Inter-Quartile Range | mg/dL | At Year 1, Year 2 and Year 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Treatment Satisfaction | The change in HIV treatment satisfaction was assessed with the help of the HIV Treatment Satisfaction questionnaire (HIVTSQs), which is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc. HIV TSQs total score: unweighted sum of 10 items of the HIV TSQs (range: 0-60; with higher scores indicating greater treatment satisfaction). | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the HIV TSQs. | Posted | Median | Inter-Quartile Range | Score on a scale | At Year 1, Year 2 and Year 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Symptom Distress | The change in HIV symptom distress was assessed with the help of the HIV Symptom Distress Module (SDM); which is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. SDM total score: unweighted sum of the 20 items (using a 5-point scale, ranging from 0-4), ranging from 0 to 80. Higher scores indicate higher degrees of symptom distress. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. This analysis was performed only on the participants from the mFAS who completed the HIV SDM. | Posted | Median | Inter-Quartile Range | Score on a scale | At Year 1, Year 2 and Year 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Reasons for Therapy Switch to JULUCA | The primary and secondary reasons for therapy switch were presented. | The analysis was performed on the mFAS which included all eligible participants who did not have any violation of inclusion or exclusion criteria which also included screening failures and major protocol deviations. | Posted | Count of Participants | Participants | At Baseline (Day 1) |
|
|
Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and All-Cause Mortality were collected from Day 1 up to maximum Year 3.
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 | Participants Who Received JULUCA | Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir [DTG] / Rilpivirine [RPV]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice. | 1 | 200 | 52 | 200 | 41 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Myopericarditis | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Acute hepatitis B | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Angiogram | Investigations | MedDRA v22.0 | Systematic Assessment |
| |
| Continuous glucose monitoring | Investigations | MedDRA v22.0 | Systematic Assessment |
| |
| Nitrite urine | Investigations | MedDRA v22.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Cerebellar stroke | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Abdominal cavity drainage | Surgical and medical procedures | MedDRA v22.0 | Systematic Assessment |
| |
| Cardioversion | Surgical and medical procedures | MedDRA v22.0 | Systematic Assessment |
| |
| Chemotherapy | Surgical and medical procedures | MedDRA v22.0 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA v22.0 | Systematic Assessment |
| |
| Mitral valve repair | Surgical and medical procedures | MedDRA v22.0 | Systematic Assessment |
| |
| Shoulder operation | Surgical and medical procedures | MedDRA v22.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA v22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA v22.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v22.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2023 | May 13, 2024 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629908 | dolutegravir, rilpivirine drug combination |
Not provided
Not provided
Not provided
|
| Title | Measurements |
|---|---|
|
| HIV-RNA 50-200 c/mL & missing subsequent measurement |
|
| Discontinuation due to intolerability & LOCF HIV-RNA <50 c/mL |
|
| Discontinuation due to death & LOCF HIV-RNA <50 c/mL |
|
| Discontinuation due to other reasons & LOCF HIV-RNA <50 c/mL |
|
| Discontinuation due to other reasons & LOCF HIV-RNA >=50 c/mL |
|
| Lost to follow-up & LOCF HIV-RNA <50 c/mL |
|
| On drug, but no HIV-RNA in window & LOCF HIV-RNA <50 c/mL |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
|
|
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|