A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

Study Overview
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Brief Summary
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A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

Official Title
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A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen Resistance data (if applicable) Exclusion Criteria: Received a regimen of darunavir/ritonavir in combination with dolutegravir for <24 weeks duration Patients receiving darunavir/ritonavir + DTG+NRTI's Missing laboratory data in ≥2 study time points Patients missing more than five doses over two weeks prior study visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |