Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs (IDOLTIB)

University of Liege

Status and phase: Unknown; Phase 3

Conditions: HIV Infections

Treatments: Drug: Treatment simplification (dolutegravir lamivudine)

Study type: Interventional

Funder types: Other

Identifiers

NCT04034862

13011987

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

2DR

Experimental group

Description:

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

Treatment:

Drug: Treatment simplification (dolutegravir lamivudine)

3DR

No Intervention group

Description:

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