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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
Last Update Posted : November 18, 2019
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 ]
    Percentage of subjects with < 20 copy RNA at 48 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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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
Last Update Posted: November 18, 2019
Last Verified: November 2019
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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Ritonavir
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
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors