Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice

NCT01375881 | Completed

• 2 other identifiers: CR017641TMC114HIV4042
• Study Type: observational
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this non-interventional study is a description of use of darunavir in daily practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual manner and in accordance with the terms of marketing authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by this study protocol but instead, it will be part of the current clinical practice. The prescription of the medicinal product will be clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures will be applied to the patients, and epidemiological methods will be used for the analysis of collected data. After having agreed with the patient on starting treatment with darunavir, and provided that all inclusion and exclusion criteria apply, the physician will document the patient's data. Patients will be observed for at least 48 weeks from baseline visit except for those who withdraw from the study earlier. Patients data will be collected at approximately 0, 1, 3 and 6 months after starting treatment and subsequently every 3 months in accordance with routine practice. The expected number of patients to enroll is about 900. The patients will be treated with darunavir according to the Italian label. The patient must be withdrawn from the study if the treatment with darunavir has been stopped. A last evaluation must be documented when possible, and a resistance test will be collected if available for patients discontinuing for virologic failure. At the end of study visit, information on therapy given after darunavir discontinuation will be collected. For patients discontinuing for virologic failure, data will be collected until the end of the present study, and at least two consecutive measurements of viral load after starting new antiretroviral therapy will be collected, if available. All data collected must be the result of the normal medical care of the patient. The patient's baseline data will be collected within the first week before darunavir administration (at Visit 1). For patients already in treatment with darunavir, baseline and follow up data will be collected retrospectively and prospectively. Further data collection will occur approximately at 1, 3, and 6 months and subsequently about every 3 months according to routine practice, after initiating darunavir treatment.

Conditions

HIV Infections

Keywords

HIV; darunavir; ritonavir; Prezista; naive; experienced

Outcome Measures

Primary Outcomes (1)

• Measurement of viral load, as an assessment of efficacy

  At least 48 weeks

Secondary Outcomes (5)

• Immunological response, as measured by CD4 cells count

  At least 48 weeks

• Impact on Health-related Quality of Life after switching to a darunavir containing regimen in accordance to the approved indication

  At least 48 weeks

• Neuropsychological impairment at baseline and after switching to a darunavir containing regimen in accordance to the approved indication

  At least 48 weeks

• Assessments of non-categorized information gathered about treatment switch to and from darunavir

  At least 48 weeks

• Number of patients with adverse events, as a measure of safety

  At least 48 weeks

Study Arms (1)

001

darunavir/ritonavir plus background regimen darunavir/ritonavir oral use in naive and experienced patients at approved dosages

Drug: darunavir/ritonavir plus background regimen

Interventions

darunavir/ritonavir plus background regimen DRUG

darunavir/ritonavir, oral use, in naive and experienced patients at approved dosages

001

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

Patient using darunavir and ritonavir in clinical practice according to label in Italy. Both naive and experienced patients are allowed to enter the study

You may qualify if:

• Having provided a signed and dated Informed Consent Form

You may not qualify if:

• A known hypersensitivity to darunavir or to any of its excipients
• Severe hepatic impairment described as Child-Pugh class C
• Pregnancy or lactation
• Patient previously treated with darunavir that was discontinued for any reason

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Janssen-Cilag S.p.A. Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 17, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 6, 2013

Record last verified: 2013-05