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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes
Hypothesis:
Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy + Doravirine Switch | Experimental | bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch | Drug | Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Suppression | Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks | 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Study Drug | Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study | Week 48 |
| Change in Body Mass Index | Assess changes in BMI due to treatment switch |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SFOMG Private Practice | San Francisco | California | 94114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biktarvy + Doravirine Switch | bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biktarvy + Doravirine Switch | bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Viral Suppression | Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks | Posted | Number | percentage of participants | 48 Weeks |
|
AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
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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 | Biktarvy + Doravirine Switch | bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New Onset Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Sterman, MD, MPH | Gilead Sciences | 415-407-8434 | Lisa.Sterman@Gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2021 | Jan 17, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2021 | Dec 20, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C000620396 | bictegravir |
| C000613801 | emtricitabine tenofovir alafenamide |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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| Week 48 |
| Work Productivity and Activity | Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI). The range of the scale is 0-10, where 0 means it did not have an affect and 10 means it did have an affect. | Week 48 |
| PK Assessment | Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®) | Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours |
| Adverse Events Assessment | Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more. | Day 28, Weeks 12, 24, 36, & 48 |
| Wellbeing Improvement | Improvement in well-being and sleep inventory as measured by The Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0 and maximum score is 21. A higher score indicates worse quality sleep. | Week 48 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Tolerability of Study Drug | Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study | Posted | Number | Adverse Events | Week 48 |
|
|
|
| Secondary | Change in Body Mass Index | Assess changes in BMI due to treatment switch | Posted | Mean | Standard Deviation | kg/m2 | Week 48 |
|
|
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| Secondary | Work Productivity and Activity | Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI). The range of the scale is 0-10, where 0 means it did not have an affect and 10 means it did have an affect. | Posted | Median | Full Range | score on a scale | Week 48 |
|
|
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| Secondary | PK Assessment | Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®) | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/ml | Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours |
|
|
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| Secondary | Adverse Events Assessment | Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more. | Posted | Number | Number of AEs | Day 28, Weeks 12, 24, 36, & 48 |
|
|
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| Secondary | Wellbeing Improvement | Improvement in well-being and sleep inventory as measured by The Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0 and maximum score is 21. A higher score indicates worse quality sleep. | Posted | Median | Full Range | score on a scale | Week 48 |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 11 |
| 20 |
| Intermittent Headache | General disorders | Non-systematic Assessment |
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| Renal Cell Carcinoma Removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Episode of Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Viral Load of 330 | Blood and lymphatic system disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Loose Stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Arthritis in Right Hand | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abdominal Pain | General disorders | Non-systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Neck Sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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