Submitted by: N/A Last Updated by: 2013-05-29 13:54:49


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

PHRR120921-000008

TMC278IFD4002

Unspecified

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.

Start Date Duration in Months Target Completion Date Actual Completion Date
2013-06-01 36 2016-06-01 0000-00-00

Suspended

The company decided to cancel this study, as per FDA circular FDA 2013-004.

Institution Classification Region LTO #
Janssen Pharmaceuticals, Inc. Private Business NCR
Institution Region
Janssen Pharmaceuticals, Inc. NCR
Name E-Mail Phone Number Postal Address
Erwin G. Benedicto, MD ebenedic@its.jnj.com 632 8248935 Janssen Pharmaceutical Companies of Johnson and Johnson Philippines Inc., Edison Road, Barrio Ibayo, 1700 Paranaque City, Philippines
Name E-Mail Phone Number Postal Address
Erwin G. Benedicto, MD ebenedic@its.jnj.com 632 8248935 Janssen Pharmaceutical Companies of Johnson and Johnson Philippines Inc., Edison Road, Barrio Ibayo, 1700 Paranaque City, Philippines
Name Expertise Affiliation
Not applicable Not applicable TBD
Project Location Institutional Ethics Review Board
TBD TBD

Human immunodeficiency virus type 1 (HIV-1) infection

Number of patients with incidence of adverse events, 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, Y. Number of patients with incidence of discontinuation of study medication due to adverse events, 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, Y.

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, N. Number of patients who will not develop virologic failure, 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, N. Number of patients who will not develop immunologic failure, 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 pretherapy CD4 baseline after 6 months of therapy; c) a 50% decline from the on-treatment peak CD4 value (if known), N. 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, AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jirovecci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc, N.

Suspended

  • Philippines

Clinical Trial

Unspecified

Unspecified

None

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

Observational

Unspecified

Unspecified

Non-randomized

Open-label

Unspecified

Single Arm

Conducted after the national drug registration authority (i.e. FDA) has approved a drug for distribution or marketing.

Phase IV

60

Unspecified

TBD - Not yet started.

01 Jun 2013

Utilization Utilization Info
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