Effect of Dolutegravir Intensification on HIV-1 Reservoirs (EDIT)

University of Liege

Status and phase: Completed; Phase 2

Conditions: HIV-1-infection

Treatments: Drug: Dolutegravir 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05351684

2018-228

Details and patient eligibility

About

Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal.

The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-infected adults receiving cART for at least 3 years
• Undetectable viral for at least 3 years
• DTG/3TC/ABC as cART regimen in the previous 6 months.
• CD4 counts higher than 200 cells per μL

Exclusion criteria

• active hepatitis C or B
• 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.
• Anal or rectal lesions impeding rectal biopsies
• Decreased platelets count or coagulation disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intensified

Experimental group

Description:

Group of patients whose treatment will be intensified with an additional 50mg of dolutegravir on top of regular treatment (Triumeq: ABC/3TC/DTG).

Treatment:

Drug: Dolutegravir 50 MG

Control

No Intervention group

Description:

Group of patients without modification of baseline treatment (Triumeq: ABC/3TC/DTG).