A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (RISE)

October 24, 2024 updated by: Janssen Research & Development, LLC

Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy

The primary purpose of the study is to evaluate the efficacy of rilpivirine (RPV)-based regimen in human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive participants, as determined by the percentage of virologic responders defined as having HIV-1 ribonucleic acid (RNA) less than 400 copies/ milliliter (mL) at Week 24.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chennai, India, 600113
        • Chennai Antiviral Research and Treatment(CART) Clinical Research Site
      • Chennai, India, 600113
        • YRGCare
      • Mangalore, India, 575001
        • Manipal University-Kasturba Medical College
      • Nagpur, India, 440001
        • Lata Mangeshkar Hospital
      • Pune, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have documented human immunodeficiency virus type 1 (HIV-1) infection
  • Must be antiretroviral (ARV) treatment-naïve
  • Have plasma HIV-1 ribonucleic acid (RNA) less than (<) 100,000 copies/milliliter (mL) at screening visit
  • Have cluster of CD4+ T-cell count (greater than) >200/ cubic millimeter (mm^3) at screening visit
  • Women of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening; and a negative urine (or serum, if required by local regulations) pregnancy test before the first dose of study

Exclusion Criteria:

  • History of any primary nucleo(t)side reverse transcriptase inhibitor (N[t]RTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations (if testing performed locally, and results are available), as defined by the current International AIDS (acquired immunodeficiency syndrome) Society-United States (USA) (International Antiviral Society-USA) 2017 guidelines
  • Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency)
  • Diagnosed with acute viral hepatitis at screening or before baseline
  • Infected with Mycobacterium tuberculosis which is likely to require rifampicin-based treatment during the study
  • Has a Grade 3 or 4 laboratory abnormality as defined by the Division of AIDS (DAIDS) for Grading the Severity of Adult and Pediatric Adverse Events criteria with the following exceptions unless clinical assessment foresees an immediate health risk to the participant: (a) Preexisting diabetes or with asymptomatic glucose Grade 3 or 4 elevations (b) Asymptomatic triglyceride or cholesterol elevations of Grade 3 or 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment: Rilpivirine+Combination Therapy (TDF/3TC)
The participants will receive antiretroviral treatment of rilpivirine 25 milligram (mg) tablet orally once daily from Day 1 for 48 weeks with a meal to improve absorption. The participants will also receive background combination therapy of 1 tablet orally once daily containing 300 mg tenofovir disoproxil fumarate (TDF) and 300 mg lamivudine (3TC).
Drug: Rilpivirine 25 mg
Participants will receive rilpivirine 25 mg tablet orally once daily.
Other Names:
  • Edurant
Drug: Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)
Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.
Other Names:
  • Tenvir-L

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at Week 24
Time Frame: Week 24
Virologic responders are defined as participants having viral load (plasma Human Immunodeficiency Virus-Type 1 Ribonucleic Acid [HIV-1 RNA] levels) less than (<) 400 copies/milliliter (mL) at Week 24 (Food and Drug Administration [FDA]-defined snapshot analysis).
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants who are Virologic Responders (HIV-1 RNA <50 Copies/mL) at Week 24
Time Frame: Week 24
Virologic responders are defined as participants having viral load (plasma HIV-1 RNA levels) <50 copies/mL at Week 24 (FDA-defined snapshot analysis).
Week 24
Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at Week 48
Time Frame: Week 48
Virologic responders are defined as participants having viral load (plasma HIV-1 RNA levels) <50, <400 and <1,000 copies/mL at Week 48 (FDA-defined snapshot analysis).
Week 48
Absolute Value in Cluster of Differentiation 4 Positive (CD4+) T-Cell Count at Weeks 24 and 48
Time Frame: At Weeks 24 and 48
CD4+T cell absolute counts will be determined at Weeks 24 and 48.
At Weeks 24 and 48
Change from Baseline in CD4+ T Cell Count at Weeks 24 and 48
Time Frame: Baseline, Weeks 24 and 48
Change from baseline in CD4+ T cell count will be determined at Weeks 24 and 48.
Baseline, Weeks 24 and 48
Percentage of Participants with Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Participants Experiencing Premature Discontinuation due to AEs Through Week 48
Time Frame: Through Week 48
Percentage of participants with Grade 3 and 4 AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants who prematurely discontinued study due to AEs will also be analyzed.
Through Week 48
Percentage of Participants with Laboratory Abnormalities
Time Frame: Up to Week 48
Percentage of participants with laboratory abnormalities will be reported.
Up to Week 48
Number of Participant with Clinically Significant Change from Baseline in Laboratory Parameters
Time Frame: Baseline up to Week 48
Number of participants with clinically significant change from baseline in laboratory parameters related to hematology, serum chemistry will be assessed.
Baseline up to Week 48
Emergence of Viral Resistance Through Weeks 24 and 48
Time Frame: Through Weeks 24 and 48
Resistance analysis will be determined using genotypic analysis at the time of virological failure (that is, 2 consecutive plasma HIV-1 RNA levels greater than or equal to [>=] 400 copies/mL through Weeks 24 and 48 of study treatment).
Through Weeks 24 and 48
Percentage of Participant with Treatment Adherence (95%) Based on Tablet Count up to Weeks 24 and 48
Time Frame: Up to Weeks 24 and 48
Percentage of adherent participants as measure of treatment compliance will be assessed by tablet count.
Up to Weeks 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108402
  • TMC278HTX3001 (Other Identifier: Johnson & Johnson Pte Ltd)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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