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

NCT ID: NCT01692470

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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rilpivirine hydrochloride

Patients will be taking 1 tablet of 25 mg rilpivirine hydrochloride is administered once daily orally in combination with other anti-retroviral (ARV) medications.

No intervention

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Edurant

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutica Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Other Identifiers

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TMC278IFD4002

Identifier Type: OTHER

Identifier Source: secondary_id

EDUPHLMA1

Identifier Type: OTHER

Identifier Source: secondary_id

CR100849

Identifier Type: -

Identifier Source: org_study_id