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Study in HIV1-Positive, Viros...

Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-22

Study Completion Date

2018-02-14

Brief Summary

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The purpose of this study is to describe the effectiveness of darunavir/cobicistat (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after baseline, defined as the day when the treatment with DRV/c-based regimen is started, through collection of daily practice data in the Italian setting.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

HIV-1-infected patients being in stable ritonavir-boosted Antiretroviral (ARV) treatment with Protease Inhibitors (PIs) (either darunavir 800 milligram \[mg\] each day -based or not) since at least twelve months and virologically suppressed (HIV-RNA less than \[\<\]50 copies/milliliters) since at least six months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult greater than or equal to (\>=18 years), male and female patients
* Documented Human Immunodeficiency Virus-1 (HIV-1) infection
* Eligible to darunavir/cobicistat (DRV/c) treatment according to Summary of Product Characteristics
* Patients who are able to understand the nature of the study and to provide their consent voluntarily having signed an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
* Patients in stable (\>= 12 months) treatment with an Antiretroviral (ARV) therapy PI/ritonavir (PI/r)-based, being prescribed Rezolsta (DRV/c) by treating physician
* Patients virosuppressed (HIV-RNA less than \[\<\] 50 copies/milliliters) since at least 6 months, within their HIV treatment at the moment of enrollment; single values of HIV-RNA more than \[\>\] 50 copies/ml not confirmed (blips) will be considered acceptable; last value collected being \< 50 copies/ml

Exclusion Criteria

* Patient currently enrolled in an interventional study
* Patient currently enrolled in an observational study sponsored or supported by Janssen
* Estimated Glomerular Filtration Rate (eGFR) \< 70 milliliters per minute (ml/min) if any co-administered agent (example emtricitabine, lamivudine, tenofovir disoproxil fumarate, or adefovir dipivoxil) requires dose adjustment based on creatinine clearance
* Pregnancy or breast feeding at enrollment
* Allergy or intolerance to sulphonamides
* Switch from darunavir/ritonavir (DRV/r) 600/100 bis in die (bid)
* Patient currently in mono PI/r therapy
* Patients to be treated within one year with Direct Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) infection
* Chemotherapy scheduled

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers