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

NCT03563742 | Terminated Phase 3

• 2 other identifiers: CR108402TMC278HTX3001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief 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 400 copies/ milliliter (mL) at Week 24.

Conditions

Human Immunodeficiency Virus Infections

Keywords

Treatment-naive; rilpivirine; India

Outcome Measures

Primary Outcomes (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).

  Week 24

Secondary Outcomes (9)

• Percentage of Participants who are Virologic Responders (HIV-1 RNA <50 Copies/mL) at Week 24

  Week 24

• Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at Week 48

  Week 48

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

  At Weeks 24 and 48

• Change from Baseline in CD4+ T Cell Count 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

  Through Week 48

Study Arms (1)

Treatment: Rilpivirine+Combination Therapy (TDF/3TC)

EXPERIMENTAL

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; Drug: Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)

Interventions

Rilpivirine 25 mg DRUG

Participants will receive rilpivirine 25 mg tablet orally once daily.

Also known as: Edurant

Treatment: Rilpivirine+Combination Therapy (TDF/3TC)

Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC) DRUG

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

Also known as: Tenvir-L

Treatment: Rilpivirine+Combination Therapy (TDF/3TC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Chennai Antiviral Research and Treatment(CART) Clinical Research Site

Chennai, 600113, India

Location

YRGCARE

Chennai, 600113, India

Location

Manipal University-Kasturba Medical College

Mangalore, 575001, India

Location

Lata Mangeshkar Hospital

Nagpur, 440001, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004, India

Location

Related Links

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

MeSH Terms

Interventions

Rilpivirine; Tenofovir

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 20, 2018
• Study Start: September 24, 2018
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

IN (5)