Clinical trial NCT01692470: A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Keywords: Human immunodeficiency virus type 1 (HIV-1) infection
HIV-1
Anti-retroviral naive
ARV
Filipino patients
Rilpivirine hydrochloride
Edurant
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of patients with incidence of adverse events
timeFrame: 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
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
timeFrame: 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
Secondary outcomes:
measure: Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment
timeFrame: Week 24, 36 and 48
measure: Number of patients who will not develop virologic failure
timeFrame: Baseline (Week 1), Week 8, Week 24 and Week 48
measure: Number of patients who will not develop immunologic failure
timeFrame: Baseline (Week 1), Week 24 and Week 48
measure: Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment
timeFrame: Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: