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)

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: Terminated
• Conditions: Human Immunodeficiency Virus Infections
• Intervention / Treatment: Drug: Rilpivirine 25 mg; Drug: Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Bengaluru, India, 560034
    • St.Johns Medical College and Hospital
  • 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

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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).	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 24
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).	Week 48
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.	At Weeks 24 and 48
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.	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	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	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	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	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	Percentage of adherent participants as measure of treatment compliance will be assessed by tablet count.	Up to Weeks 24 and 48

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pte Ltd

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: India; rilpivirine; Treatment-naive
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Lamivudine; Rilpivirine
• Other Study ID 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