NCT05351684

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

3.7 years

First QC Date

October 24, 2019

Last Update Submit

December 14, 2022

Conditions

HIV-1-infection

Outcome Measures

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.

    Measurements of blood and tissue HIV reservoir

    3 months

Secondary Outcomes (5)

  • To evaluate the impact of DTG treatment intensification on residual viremia

    3 months

  • To evaluate the impact of DTG treatment intensification on immune activation

    3 months

  • To investigate the correlation between blood and tissues HIV reservoir

    3 months

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

    3 months

  • To evaluate the impact of DTG treatment intensification on inflammation

    3 months

Study Arms (2)

Intensified

EXPERIMENTAL

Group of patients whose treatment will be intensified with an additional 50mg of dolutegravir on top of regular treatment (Triumeq: ABC/3TC/DTG).

Drug: Dolutegravir 50 MG

Control

NO INTERVENTION

Group of patients without modification of baseline treatment (Triumeq: ABC/3TC/DTG).

Interventions

Dolutegravir 50 MGDRUG

already included in arm/group descriptions.

Intensified

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liège university hospital

Liège, 4000, Belgium

Location

Related Publications (1)

  • Fombellida-Lopez C, Valaitiene A, Winchester L, Maes N, Dellot P, Vanwinge C, Ladang A, Cavalier E, Susin F, Vaira D, Hayette MP, Reenaers C, Moutschen M, Fletcher CV, Pasternak AO, Darcis G. Doubling dolutegravir dosage reduces the viral reservoir in ART-treated people with HIV. Elife. 2026 Jan 23;14:RP106931. doi: 10.7554/eLife.106931.

    PMID: 41575190DERIVED

MeSH Terms

Interventions

dolutegravir

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2019

First Posted

April 28, 2022

Study Start

January 1, 2019

Primary Completion

August 28, 2022

Study Completion

December 13, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

BE(1)