NCT05917509

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

A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-09-16
• Completion: 2026-04-22
• First posted: 2023-06-26
• Last updated: 2026-03-09

Locations

47 sites across 9 countries: United States, Argentina, Canada, Chile, France, Germany, Italy, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study