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

Completed

• Conditions: HIV-1-infection

• Registration Number: NCT03198884
• Lead Sponsor: Southern Illinois Healthcare Foundation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Primary Completion: 2018-04-18
• Study Completion: 2018-05-01
• Results First Submitted: 2020-01-29
• Results First Submitted QC: 2020-06-19
• Results First Posted: 2020-07-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With RNA <50 Copies/mL at 48 Weeks	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.	48 weeks	A second primary endpoint was evaluating the change in serum creatinine from baseline to 48 weeks for all subjects.

Secondary Outcome Measures

Name	Time	Method
Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks.	48 weeks
Change in Mean CD4+ Cell Count From Baseline.	48 weeks	A secondary endpoint included changes from baseline in CD4+ cell counts.
Incidence of Adverse Events.	48 weeks	10 study subjects reported an adverse event.
Number of Grade 1 Adverse Events Reported	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.
Number of Participants With RNA <50 Copies/mL at 24, 36, and 48 Weeks	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.