A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection

The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.

Study Overview

• Status: Withdrawn
• Conditions: Human Immunodeficiency Virus-Type 1
• Intervention / Treatment: Drug: No intervention

Detailed Description

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients. The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult Filipino patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment.

Description

Inclusion Criteria:

• Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment. These may be either: treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions; or treatment-experienced adult patients with at least one darunavir resistance associated substitution

Exclusion Criteria:

• Known hypersensitivity to darunavir/ritonavir or to any of the components of the two agent preparations
• Pregnant or breastfeeding females
• Agrees to protocol-defined use of effective contraception
• Patients taking medication that are highly dependent on Cytochrome P450 3A4 for clearance and for which initial concentrations are associated with serious and/or life threatening events
• Patients with severe hepatic impairment
• History of allergy to sulfa containing drugs or molecules
• Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort (Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Darunavir; Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.

Drug: No intervention; This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with incidence of adverse events	Up to 24 weeks
Number of patients with incidence of discontinuation of study medication due to adverse events	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean decrease of viral load at the end of treatment from baseline		Baseline, Week 12, and Week 24
Number of patients with viral load of 50 copies per ml at the end of treatment		Baseline, Week 12, and Week 24
Number of patients with lack of effect	Any failure of expected pharmacologic action of the study medication	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: HIV-1; Ritonavir; Darunavir; TMC114; Filipino; Human Immunodeficiency Virus-Type 1
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: CR014686; TMC114HIV4013 (Other Identifier: Janssen Pharmaceutica); PRE-PHL-MA1 (Other Identifier: Janssen Pharmaceutica); TMC-C-07-PH-007 (Other Identifier: Janssen Pharmaceutica)