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AzTrials

Human Immunodeficiency Virus InfectionsPhase 3RISENCT03563742

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

A Phase 3 study testing Rilpivirine 25 mg and Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC) in people with Human Immunodeficiency Virus Infections, run by Janssen Research & Development, LLC at 5 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus Infections
What is being tested?
Rilpivirine 25 mg and Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
5 sitesIndia
Study dates
24 Sep 2018to 28 Jun 2021
Phase
Phase 3
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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

India5 sites

  • Chennai Antiviral Research and Treatment(CART) Clinical Research Site

    Chennai, 600113

  • YRGCARE

    Chennai, 600113

  • Manipal University-Kasturba Medical College

    Mangalore, 575001

  • Lata Mangeshkar Hospital

    Nagpur, 440001

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

Other trials in India

About this study

Official title: 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.

Being tested
Rilpivirine 25 mg, Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)
Keywords
Treatment-naive, rilpivirine, India

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rilpivirine 25 mgDrug

    Also called Edurant

    Participants will receive rilpivirine 25 mg tablet orally once daily.

  • Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)Drug

    Also called Tenvir-L

    Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.

Study groups in NCT03563742
Study groupRoleWhat they receive
Treatment: Rilpivirine+Combination Therapy (TDF/3TC)ExperimentalThe 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).
Receives: Drug: Rilpivirine 25 mg; Drug: Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at 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).

    Measured: Week 24

Secondary outcomes (9)

  1. Percentage of Participants who are Virologic Responders (HIV-1 RNA <50 Copies/mL) at 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).

    Measured: Week 24

  2. Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at 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).

    Measured: Week 48

  3. Absolute Value in Cluster of Differentiation 4 Positive (CD4+) T-Cell Count at Weeks 24 and 48

    CD4+T cell absolute counts will be determined at Weeks 24 and 48.

    Measured: At Weeks 24 and 48

  4. Change from Baseline in CD4+ T Cell Count at Weeks 24 and 48

    Change from baseline in CD4+ T cell count will be determined at Weeks 24 and 48.

    Measured: Baseline, Weeks 24 and 48

  5. 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

    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.

    Measured: Through Week 48

  6. Percentage of Participants with Laboratory Abnormalities

    Percentage of participants with laboratory abnormalities will be reported.

    Measured: Up to Week 48

  7. Number of Participant with Clinically Significant Change from Baseline in Laboratory Parameters

    Number of participants with clinically significant change from baseline in laboratory parameters related to hematology, serum chemistry will be assessed.

    Measured: Baseline up to Week 48

  8. Emergence of Viral Resistance 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).

    Measured: Through Weeks 24 and 48

  9. Percentage of Participant with Treatment Adherence (95%) Based on Tablet Count up to Weeks 24 and 48

    Percentage of adherent participants as measure of treatment compliance will be assessed by tablet count.

    Measured: Up to Weeks 24 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start24 Sep 2018
  3. Primary completion28 Jun 2021
  4. Study completion28 Jun 2021

Why it stopped: High SF rate (less treatment-naïve subjects \& subjects with viral load \<100000). Reevaluation in scientific position in India after internal discussion.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563742
Sponsor's protocol ID
CR108402
Other IDs
TMC278HTX3001
Acronym
RISE
Status last verified
Oct 2024
First submitted
28 May 2018
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilpivirine 25 mg and Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC) in people with Human Immunodeficiency Virus Infections, run by Janssen Research & Development, LLC at 5 sites in India.

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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: High SF rate (less treatment-naïve subjects \& subjects with viral load \<100000). Reevaluation in scientific position in India after internal discussion.). Results are not available in the source record.

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?

Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563742.

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 28 Oct 2024.

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