Human Immunodeficiency Virus Type 1 (HIV-1) InfectionNCT01692470
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
An observational study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, run by Janssen Pharmaceutica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Human immunodeficiency virus type 1 (HIV-1) infection, HIV-1, Anti-retroviral naive, ARV, Filipino patients, Rilpivirine hydrochloride, Edurant
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
Also called Edurant
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incidence of adverse events
Measured: 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
Measured: 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 (4)
Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment
Measured: Week 24, 36 and 48
Number of patients who will not develop virologic failure
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.
Measured: Baseline (Week 1), Week 8, Week 24 and Week 48
Number of patients who will not develop immunologic failure
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)
Measured: Baseline (Week 1), Week 24 and Week 48
Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment
AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.
Measured: Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692470
- Sponsor's protocol ID
- CR100849
- Other IDs
- TMC278IFD4002, EDUPHLMA1
- Status last verified
- Nov 2015
- First submitted
- 21 Sep 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01692470
- Acronym / sponsor ID
- CR100849
- Keywords
- Human immunodeficiency virus type 1 (HIV-1) infection, HIV-1, Anti-retroviral naive, ARV, Filipino patients, Rilpivirine hydrochloride, Edurant
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rilpivirine hydrochloride | – | Drug: No interventionPatients will be taking 1 tablet of 25 mg rilpivirine hydrochloride is administered once daily orally in combination with other anti-retroviral (ARV) medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: EdurantPatients 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. | Drug | rilpivirine hydrochloride |
Primary outcome
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
4 secondary outcomes
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
Number of patients who will not develop immunologic failure
Time frame: Baseline (Week 1), Week 24 and Week 48
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica Clinical Trial study director
Janssen Pharmaceutica
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, run by Janssen Pharmaceutica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.