Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: Treatment simplification (dolutegravir lamivudine)

• Registration Number: NCT04034862
• Lead Sponsor: University of Liege

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Study Start: 2019-10-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• HIV-infected adults receiving cART for at least 2 years
• DTG/3TC/ABC as cART regimen in the previous 6 months.
• CD4 counts higher than 200 cells per μL and virological suppression for at least 2 years (plasma HIV RNA <20 copies per mL)

Exclusion Criteria

• hepatitis C or B co-infection
• unstable liver disease
• renal impairment (estimated glomerular filtration rate <50 mL per min),
• gastrointestinal disorders that would affect the absorption of study treatment
• current use of drugs with significant interactions with dolutegravir
• current use of drugs with an impact on inflammation such as steroids.
• hospitalization for acute illness within the previous 8 weeks
• Pregnancy or breastfeeding.
• Known resistance to DTG or 3TC
• Active tuberculosis
• Anal or rectal lesions impeding rectal biopsies
• Decreased platelets count or coagulation disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2DR	Treatment simplification (dolutegravir lamivudine)	Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)

Primary Outcome Measures

Name	Time	Method
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.	1 year	Measurements of RCR in the blood and tissues (rectal biopsies)

Secondary Outcome Measures

Name	Time	Method
The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.	1 year
The level of clonal expansion in the blood and tissue RCR	1 year
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.	1 year
The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.	1 year
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.	1 year

Trial Locations

Locations (1)

Liège university hospital; 🇧🇪 Liège, Belgium