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

Phase 3 Terminated 58 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2018-09-24
Primary completion: 2021-06-28
Completion: 2021-06-28

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rilpivirine	Small molecule	25 mg	Oral
Background	Lamivudine	Other / unclassified	300 mg	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral

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

Summary

Timeline

Drugs

Indications