Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

NCT ID: NCT04034862

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-06-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2DR

Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)

Group Type: EXPERIMENTAL

Treatment simplification (dolutegravir lamivudine)

Intervention Type: DRUG

Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

3DR

Continued 3 drug regimen treatment (DTG+ABC+3TC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Treatment simplification (dolutegravir lamivudine)

Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Gilles Darcis

Head of clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilles Darcis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Liege University Hospital

Locations

Liège university hospital

Liège, Liège, Belgium

Countries

Belgium

Other Identifiers

13011987

Identifier Type: -

Identifier Source: org_study_id