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A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05917509 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-03-09

No results posted yet for this study

Summary

This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 \<50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.

Conditions

  • HIV Infections

Interventions

DRUG

DTG/3TC

DTG/3TC FDC will be administered as an oral once daily tablet.

DRUG

Cabotegravir (CAB) LA

CAB LA will be administered as a gluteal intramuscular injection once every 2 months in combination with RPV LA.

DRUG

Rilpivirine (RPV) LA

RPV LA will be administered as a gluteal intramuscular injection once every 2 months in combination with CAB LA.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2025-09-16
Completion
2026-04-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • France
  • Germany
  • Italy
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT05917509 on ClinicalTrials.gov