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OpenTrials
Completed

NCT Number: NCT05351684

Effect of Dolutegravir Intensification on HIV-1 Reservoirs

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.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liège university hospital

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dolutegravir 50 mg

Drug

already included in arm/group descriptions.

Primary outcomes

  1. To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues.

    Time frame: 3 months

    Measurements of blood and tissue HIV reservoir

Secondary outcomes

  1. To evaluate the impact of DTG treatment intensification on residual viremia

    Time frame: 3 months

    Measurement of HIV viremia at the single copy level

  2. To evaluate the impact of DTG treatment intensification on immune activation

    Time frame: 3 months

    Measurement of T cell activation markers

  3. To investigate the correlation between blood and tissues HIV reservoir

    Time frame: 3 months

    Measurement of blood and tissue HIV reservoir

  4. To correlate the concentration of DTG with residual viremia and impact on HIV reservoir

    Time frame: 3 months

    Measurement of DTG blood concentration

  5. To evaluate the impact of DTG treatment intensification on inflammation

    Time frame: 3 months

    Measurement on inflammatory markers in blood

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Effect of Dolutegravir Intensification on Blood and Tissue Latent HIV-1 Reservoirs and on Residual Viremia Despite ART

Acronym: EDIT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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