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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198884
Recruitment Status : Completed
First Posted : June 26, 2017
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
John Verna, 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

Condition or disease Intervention/treatment
HIV-1-infection Drug: Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Change in Mean CD4+ Cell Count From Baseline. [ Time Frame: 48 weeks ]
    A secondary endpoint included changes from baseline in CD4+ cell counts.

  2. Incidence of Adverse Events. [ Time Frame: 48 weeks ]
    10 study subjects reported an adverse event.

  3. 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.


  4. 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.


  5. Analysis of Creatinine Clearance at Time Points 24, 36 and 48 Weeks. [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult HIV positive patients
Criteria

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 Documents (Full-Text)

Documents provided by John Verna, Southern Illinois Healthcare Foundation:
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Responsible Party: John Verna, Physician Assistant, Southern Illinois Healthcare Foundation
ClinicalTrials.gov Identifier: NCT03198884    
Other Study ID Numbers: 16-1108-100C
First Posted: June 26, 2017    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share.

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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
Additional relevant MeSH terms:
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Darunavir
Dolutegravir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors