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)

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 3

Conditions: Human Immunodeficiency Virus Infections

Treatments: Drug: Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC); Drug: Rilpivirine 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03563742

TMC278HTX3001 (Other Identifier)

CR108402

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

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

Experimental group

Description:

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).

Treatment:

Drug: Rilpivirine 25 mg

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