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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Drug: No intervention
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 0
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)
Groups/Cohorts Assigned 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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692470

Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01692470     History of Changes
Other Study ID Numbers: CR100849, TMC278IFD4002, EDUPHLMA1
Study First Received: September 21, 2012
Last Updated: September 24, 2013
Health Authority: Philippine: Food and Drug Administration

Keywords provided by Janssen Pharmaceutica:
Human immunodeficiency virus type 1 (HIV-1) infection
HIV-1
Anti-retroviral naive
ARV
Filipino patients
Rilpivirine hydrochloride
Edurant

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Virus Diseases
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014