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

This study has been withdrawn prior to enrollment.
(The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01692470
First received: September 21, 2012
Last updated: September 24, 2013
Last verified: September 2013

September 21, 2012
September 24, 2013
June 2013
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01692470 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 jirovecci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.
Not Provided
Not Provided
 
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
A Post-Marketing Surveillance Study on the Safety and Effectiveness of Rilpivirine Hydrochloride 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Filipino anti-retroviral (ARV) naive patients with human immunodeficiency virus type 1 (HIV-1) infection and who are using rilpivirine upon its local registration

Human Immunodeficiency Virus Type 1 (HIV-1) Infection
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
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: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01692470
CR100849, TMC278IFD4002, EDUPHLMA1
No
Janssen Pharmaceutica
Janssen Pharmaceutica
Not Provided
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
Janssen Pharmaceutica
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP