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

NCT02926456 | Completed

• 2 other identifiers: CR108148TMC114FD1HTX4003
• Study Type: observational
• Target: 337
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48

  The percentage of patients with plasma HIV-RNA\<50 copies/mL will be analyzed by FDA snapshot analysis (FDA Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA \<50 copies/mL (observed case); If there are no data in the defined time window, the proportion of missing data and relative reason will be provided") and Time to loss of virologic response (TLOVR) method algorithm requires sustained HIV-1 RNA \< 50 copies/mL; confirmed HIV-1 RNA more than or equal to (\>=) 50 copies/mL is considered as non-response (rebound); patients considered non-responder after permanent discontinuation).

  At Visit 4 (Week 48)

Secondary Outcomes (17)

• Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score

  Baseline, Up to Visit 4 (Week 48)

• Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score

  Baseline, Up to Visit 4 (Week 48)

• Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24

  At Visit 3 (Week 24)

• Change From Baseline in CD4 Cell Count

  Baseline, Up to Visit 4 (Week 48)

• Change From Baseline in CD4/CD8 Ratio

  Baseline, Up to Visit 4 (Week 48)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult out-patients with a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1), belonging to Italian Infectious Disease Hospital departments of Italian specialty hospitals.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Janssen-Cilag S.p.A., Italy Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 6, 2016
• Study Start: July 22, 2016
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04