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

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

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult HIV positive patients

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Southern Illinois Healthcare Foundation
• Collaborators: Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): April 18, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (ACTUAL): June 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Darunavir; Dolutegravir
• Other Study ID Numbers: 16-1108-100C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No