A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
|ClinicalTrials.gov Identifier: NCT01692470|
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004)
First Posted : September 25, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Type 1 (HIV-1) Infection||Drug: No intervention||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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
- 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 ]
- 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 ]
- Number of patients who will not develop virologic failure [ Time Frame: Baseline (Week 1), Week 8, Week 24 and Week 48 ]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 ]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 ]AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692470
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|