NCT01692470

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

September 21, 2012

Last Update Submit

November 30, 2015

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Keywords

Human immunodeficiency virus type 1 (HIV-1) infectionHIV-1Anti-retroviral naiveARVFilipino patientsRilpivirine hydrochlorideEdurant

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

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

    Week 24, 36 and 48

  • Number of patients who will not develop virologic failure

    Baseline (Week 1), Week 8, Week 24 and Week 48

  • Number of patients who will not develop immunologic failure

    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

    Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48

Study Arms (1)

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

Interventions

No interventionDRUG

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.

Also known as: Edurant
rilpivirine hydrochloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeInfections

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen Pharmaceutica Clinical Trial

    Janssen Pharmaceutica

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 25, 2012

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11