Status:
COMPLETED
Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs
Lead Sponsor:
University of Liege
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04034862
Start Date
October 1 2019
End Date
June 30 2023
Last Update
March 17 2025
Active Locations (1)
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1
Liège university hospital
Liège, Liège, Belgium, 4000