Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

• Status: Not yet recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liege
• Treatments: Dolutegravir; Lamivudine

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.