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

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    20
  • sponsor
    University of Liege
Updated on 17 May 2022

Summary

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.

Details
Condition HIV-1-infection
Treatment Dolutegravir 50 mg
Clinical Study IdentifierNCT05351684
SponsorUniversity of Liege
Last Modified on17 May 2022

Eligibility

Yes No Not Sure

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
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