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

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Rilpivirine

Criteria

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