Effect of Dolutegravir Intensification on HIV-1 Reservoirs
NCT ID: NCT05351684
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2019-01-01
2022-12-13
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensified
Group of patients whose treatment will be intensified with an additional 50mg of dolutegravir on top of regular treatment (Triumeq: ABC/3TC/DTG).
Dolutegravir 50 MG
already included in arm/group descriptions.
Control
Group of patients without modification of baseline treatment (Triumeq: ABC/3TC/DTG).
No interventions assigned to this group
Interventions
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Dolutegravir 50 MG
already included in arm/group descriptions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Liege
OTHER
Responsible Party
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Gilles Darcis
Principal Investigator
Locations
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Liège university hospital
Liège, , Belgium
Countries
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Other Identifiers
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2018-228
Identifier Type: -
Identifier Source: org_study_id