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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198884
• Other study ID #: 16-1108-100C
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2020
• Source: Southern Illinois Healthcare Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southern Illinois Healthcare Foundation	Janssen Scientific Affairs, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	48 weeks
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.	48 weeks
Secondary	Change in Mean CD4+ Cell Count From Baseline.	A secondary endpoint included changes from baseline in CD4+ cell counts.	48 weeks
Secondary	Incidence of Adverse Events.	10 study subjects reported an adverse event.	48 weeks
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.	48 weeks
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.	48 weeks
Secondary	Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks.		48 weeks