A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
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ClinicalTrials.gov Identifier: NCT03198884
Recruitment Status :
First Posted : June 26, 2017
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Southern Illinois Healthcare Foundation
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
John Verna, Southern Illinois Healthcare Foundation
HIV RNA Quantitative Testing (Serum) [ Time Frame: 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.
The Change in Serum Creatinine From Baseline to 48 Weeks. [ Time Frame: 48 weeks ]
A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects.
Secondary Outcome Measures :
Change in Mean CD4+ Cell Count From Baseline. [ Time Frame: 48 weeks ]
A secondary endpoint included changes from baseline in CD4+ cell counts.
Incidence of Adverse Events. [ Time Frame: 48 weeks ]
10 study subjects reported an adverse event.
Number of Grade 1 Adverse Events Reported [ Time Frame: 48 weeks ]
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.
Analysis of RNA at Time Points 24, 36 and 48 Weeks. [ Time Frame: 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.
Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks. [ Time Frame: 48 weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult HIV positive patients
≥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)
Received a regimen of darunavir/ritonavir in combination with dolutegravir for <24 weeks duration