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Completed

NCT Number: NCT03198884

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

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG

Drug

Primary outcomes

  1. Number of Participants With RNA <50 Copies/mL at 48 Weeks

    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 outcomes

  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. Number of Participants With RNA <50 Copies/mL at 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

Sponsors and collaborators

Lead sponsor

Southern Illinois Healthcare Foundation

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2017
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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