A Post-Marketing Surveillance Study on the Safety and Effectiveness of Rilpivirine Hydrochloride Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Janssen Pharmaceutica
- Primary Endpoint
- Number of patients with incidence of adverse events
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: No intervention (Drug)
Outcomes
Primary Outcomes
Number of patients with incidence of adverse events
Time Frame: 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
Number of patients with incidence of discontinuation of study medication due to adverse events
Time Frame: 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
Secondary Outcomes
- 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)
- Number of patients who will not develop virologic failure(Baseline (Week 1), Week 8, Week 24 and Week 48)
- Number of patients who will not develop immunologic failure(Baseline (Week 1), Week 24 and Week 48)
- Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment(Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48)