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

Janssen (J&J Innovative Medicine)

Status: Withdrawn

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01692470

TMC278IFD4002 (Other Identifier)

EDUPHLMA1 (Other Identifier)

CR100849

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

rilpivirine hydrochloride

Description:

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

Treatment:

Drug: No intervention