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A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

NCT04542070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 687

Last updated 2024-06-04

Study results available
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Summary

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Conditions

  • HIV Infections

Interventions

DRUG

Cabotegravir Tablets

CAB tablets were available as film coated tablets for oral administration.

DRUG

Cabotegravir Injectable Suspension (CAB LA)

CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection.

DRUG

Rilpivirine Tablets

RPV was administered as tablets for oral administration.

DRUG

Rilpivirine Injectable Suspension (RPV LA)

RPV LA was available as a sterile suspension of RPV to be administered as an IM injection.

DRUG

BIKTARVY Tablets (BIK)

BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2022-07-13
Completion
2023-04-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

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 NCT04542070 on ClinicalTrials.gov