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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With RNA <50 Copies/mL at 48 Weeks | Our first primary endpoint evaluated the percent of study subjects with an RNA <50 copies/mL at 48 weeks after initiation of the once daily two-drug regimen. | 48 weeks |
| The Change in Serum Creatinine From Baseline to 48 Weeks. | A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean CD4+ Cell Count From Baseline. | A secondary endpoint included changes from baseline in CD4+ cell counts. | 48 weeks |
| Incidence of Adverse Events. | 10 study subjects reported an adverse event. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult HIV positive patients
No plan to share.
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Subjects included were at least 18 years of age, receiving DRV/r + DTG QD for at least 24 weeks and had laboratory data through 48 weeks of follow up. Those excluded were not taking the study regimen, missed more than five doses of medication over two weeks prior to study visit or if there was missing lab data for 2 or more study time points.
A retrospective chart review of appoximately 400 HIV+ patients receiving treatment at an urban diverse FQHC was conducted to identify those who were receiving an NRTI-sparing regimen of DRV and DTG.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective Chart Review | We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2019 |
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| 48 weeks |
| Number of Grade 1 Adverse Events Reported | 10 study subjects reported adverse events. All adverse events reported (insomnia, diarrhea, headache) were of Grade 1 severity. There were no adverse events that led to discontinuation of the study regimen. | 48 weeks |
| Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks | This secondary outcome measure analyzed the percentage of subjects with < 50 copies/mL RNA at time points 24, 36 and 48 weeks. The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. | 48 weeks |
| Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks. | 48 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Retrospective Chart Review | We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks. |
| 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 |
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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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| HIV RNA (copies/mL) | This measurement was conducted at the start and at the conclusion of the study for each participant. The range 20 copies/mL to 1,820,101 copies/mL represents the HIV RNA range recorded in study subjects. | Median | Full Range | copies/mL |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With RNA <50 Copies/mL at 48 Weeks | Our first primary endpoint evaluated the percent of study subjects with an RNA <50 copies/mL at 48 weeks after initiation of the once daily two-drug regimen. | 19 patients meeting the inclusion criteria were analyzed for this study. We evaluated the percentage of study subjects with an HIV RNA < 50 copies at 48 weeks after initiation of the once daily two-drug regimen. | Posted | Count of Participants | Participants | 48 weeks |
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| Primary | The Change in Serum Creatinine From Baseline to 48 Weeks. | A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects. | Posted | Mean | Full Range | mg/dL | 48 weeks |
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| Secondary | Change in Mean CD4+ Cell Count From Baseline. | A secondary endpoint included changes from baseline in CD4+ cell counts. | For week 36 data, 6 study subjects did not have reportable data. These missing data included patient no-shows for labs and lab error (ex, lost sample, insufficient blood/serum drawn to run test). | Posted | Mean | Standard Deviation | cells/μL | 48 weeks |
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| Secondary | Incidence of Adverse Events. | 10 study subjects reported an adverse event. | Posted | Count of Participants | Participants | 48 weeks |
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| Secondary | Number of Grade 1 Adverse Events Reported | 10 study subjects reported adverse events. All adverse events reported (insomnia, diarrhea, headache) were of Grade 1 severity. There were no adverse events that led to discontinuation of the study regimen. | 20 patients were evaluted for adverse events. | Posted | Number | Adverse Events | 48 weeks |
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| Secondary | Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks | This secondary outcome measure analyzed the percentage of subjects with < 50 copies/mL RNA at time points 24, 36 and 48 weeks. The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. | We analyzed data for all participants as indicated in the data table. There was missing data for one study subject at week 24 of the study and missing data for six study subjects at week 36 (blood draws were not completed by patients). Also, data was missing for one study subject at week 48 (blood draw not completed secondary incarceration). | Posted | Count of Participants | Participants | 48 weeks |
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| Secondary | Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks. | There was missing data for one study subject at week 24 of the study and missing data for six study subjects at week 36 (blood draws were not completed by patients). In addition, data was missing for one study subject at week 48 (blood draw not completed secondary incarceration). | Posted | Mean | Full Range | mg/dL | 48 weeks |
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Adverse event data was collected for a total of 3 months.
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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 | Retrospective Chart Review | We conducted a retrospective chart review of approximately 400 HIV+ patients receiving treatment at an urban diverse FQHC to identify those who were receiving a NRTI-sparing regimen of DRV and DTG. Subjects were included if they were ≥ 18 years of age, receiving DRV/r + DTG QD for ≥ 24 weeks, and had laboratory data through 48 weeks of follow up. Subjects were excluded if they received a regimen of DRV/r in combination with DTG for <24 weeks duration, if they received DRV/r + DTG + NRTI's, missed more than five doses over two weeks prior to study visit or if there was missing laboratory data for ≥2 or more study time points. The primary endpoints evaluated were the percent of patients with an RNA <50 copies/mL at 48 weeks after initiation of the regimen, as well as, the change in serum creatinine from baseline to 48 weeks. | 0 | 20 | 0 | 20 | 10 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | Nervous system disorders | Systematic Assessment | Insomnia |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea |
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| Headache | Nervous system disorders | Systematic Assessment | Headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Verna | SIHF Healthcare | 618-337-8153 | jverna@sihf.org |
| Feb 10, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| C562325 | dolutegravir |
| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Analysis of HIV RNA at Week 48 | At week 48, 95% of subjects had an RNA of < 50 copies/mL. The percent of subjects with an RNA < 50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. |
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