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

Human Immunodeficiency Virus-Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01726348
• Other study ID #: CR014686
• Secondary ID: TMC114HIV4013PRE
• Status: Withdrawn
• Phase: Phase 4
• First received: November 9, 2012
• Last updated: November 30, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Janssen Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippine: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus-Type 1
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with incidence of adverse events		Up to 24 weeks	Yes
Primary	Number of patients with incidence of discontinuation of study medication due to adverse events		Up to 24 weeks	Yes
Secondary	Mean decrease of viral load at the end of treatment from baseline		Baseline, Week 12, and Week 24	No
Secondary	Number of patients with viral load of 50 copies per ml at the end of treatment		Baseline, Week 12, and Week 24	No
Secondary	Number of patients with lack of effect	Any failure of expected pharmacologic action of the study medication	Up to 24 weeks	No