A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection

Human Immunodeficiency Virus Type 1 (HIV-1) Infection Clinical Trial

Official title:

A Post-Marketing Surveillance Study on the Safety and Effectiveness of Rilpivirine Hydrochloride Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01692470
• Other study ID #: CR100849
• Secondary ID: TMC278IFD4002EDU
• Status: Withdrawn
• Phase: Phase 4
• First received: September 21, 2012
• Last updated: November 30, 2015
• Start date: June 2013
• Est. completion date: December 2015

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 rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human immunodeficiency virus type 1 (HIV-1) infection.

Description:

This is an open-label (all people know the identity of the study medication), multi-center, observational (study in which the investigators/ physicians observe the patients and measure their outcomes) study. The total duration of the study will be 3 years, and approximately 60 patients who would use rilpivirine hydrochloride in routine clinical practice with a dosing regimen stipulated in the product insert (ie, 25 mg once a day) will be enrolled. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored from baseline and throughout the 48-week (2nd, 4th, 8th, 12th, 24th, 36th and 48th weeks) treatment period of rilpivirine hydrochloride.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Filipino patients

• ARV naive patients with HIV-1 infection who are assessed by the physician to be eligible for treatment with ARVs

• Patients who voluntarily signed the informed consent form

Exclusion Criteria:

• Patients receiving drugs known to prolong QTc intervals, medicinal products with a known risk of Torsade de Pointes and anticonvulsants, systemic dexamethasone, proton pump inhibitors

• Any previous treatment for HIV

• Previously documented HIV-2 infection

• Patients with viral load of >100,000 HIV-1 ribo nucleic acid (RNA) copies/ml

• Severely ill patients like those with acute acquired immune deficiency syndrome (AIDS)-defining illness or other major concomitant - disease prior to enrolment

• Patients with severe hepatic impairment

• Known hypersensitivity to rilpivirine hydrochloride

• Pregnant or breastfeeding females

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Human Immunodeficiency Virus Type 1 (HIV-1) Infection
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• No intervention
Patients will be taking rilpivirine hydrochloride as per the dosing regimen given on product insert approved in Philippines (ie, 1 tablet of 25 mg orally once a day) in combination with anti-retroviral (ARV) medications.

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		From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years	Yes
Primary	Number of patients with incidence of discontinuation of study medication due to adverse events		From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years	Yes
Secondary	Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment		Week 24, 36 and 48	No
Secondary	Number of patients who will not develop virologic failure	Virologic failure defined as a persistently detectable viral load in a patient with previously suppressed human immunodeficiency virus ribo nucleic acid (HIV RNA) or the inability to achieve an undetectable viral load after 24 weeks of therapy. The level of undetectable load is less than 50 HIV-1 RNA copies/ml.	Baseline (Week 1), Week 8, Week 24 and Week 48	No
Secondary	Number of patients who will not develop immunologic failure	Immunologic failure defined as either of the following conditions: a) CD4 count below 100 cells/mm3 after 6 months of therapy; b) return to or a fall below, the pre-therapy CD4 baseline after 6 months of therapy; c) a 50% decline from the on-treatment peak CD4 value (if known)	Baseline (Week 1), Week 24 and Week 48	No
Secondary	Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment	AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.	Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48	No