A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
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.
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Drug: No intervention
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment [ Time Frame: Week 24, 36 and 48 ] [ Designated as safety issue: No ]
- Number of patients who will not develop virologic failure [ Time Frame: Baseline (Week 1), Week 8, Week 24 and Week 48 ] [ Designated as safety issue: No ]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.
- Number of patients who will not develop immunologic failure [ Time Frame: Baseline (Week 1), Week 24 and Week 48 ] [ Designated as safety issue: No ]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)
- Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment [ Time Frame: Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48 ] [ Designated as safety issue: No ]AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients will be taking 1 tablet of 25 mg rilpivirine hydrochloride is administered once daily orally in combination with other anti-retroviral (ARV) medications.
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.
Other Name: Edurant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692470
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|