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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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-10-28

No results posted yet for this study

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

Interventions

DRUG

Rilpivirine 25 mg

Participants will receive rilpivirine 25 mg tablet orally once daily.

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563742 on ClinicalTrials.gov