NCT04034862

Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For a few years, there has been a keen interest of clinicians and patients for "lighter" antiretroviral strategies based on two- or even single drug regimens rather than the canonical triple therapy, both as initial and maintenance therapy, despite the possibility that ongoing viral replication may occur in some patients under triple-therapy. We will therefore propose such simplification strategy (DTG/3TC) while maintaining triple-therapy (DTG/ABC/3TC) in a control group and will perform an in depth analysis of the replication-competent reservoir in blood and in tissues as well as measurements of residual viremia and immune chronic activation/inflammation.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Treatment simplification (dolutegravir lamivudine)	Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-03-01
• Completion: 2023-06-30
• First posted: 2019-07-26
• Last updated: 2025-03-17

Locations

1 site across 1 country: Belgium