NCT04034862

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, both as initial and maintenance therapy, despite the possibility that ongoing viral replication may occur in some patients under triple-therapy. We will therefore propose such simplification strategy (DTG/3TC) while maintaining triple-therapy (DTG/ABC/3TC) in a control group and will perform an in depth analysis of the replication-competent reservoir in blood and in tissues as well as measurements of residual viremia and immune chronic activation/inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Oct 2019

Typical duration for phase_3 hiv-infections

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

First Submitted

Initial submission to the registry

July 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 17, 2025

Status Verified

January 1, 2025

Enrollment Period

3.4 years

First QC Date

July 17, 2019

Last Update Submit

March 12, 2025

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.

    Measurements of RCR in the blood and tissues (rectal biopsies)

    1 year

Secondary Outcomes (5)

  • The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.

    1 year

  • The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.

    1 year

  • The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.

    1 year

  • The level of clonal expansion in the blood and tissue RCR

    1 year

  • The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.

    1 year

Study Arms (2)

2DR

EXPERIMENTAL

Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)

Drug: Treatment simplification (dolutegravir lamivudine)

3DR

NO INTERVENTION

Continued 3 drug regimen treatment (DTG+ABC+3TC)

Interventions

Treatment simplification (dolutegravir lamivudine)DRUG

Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

2DR

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 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liège university hospital

Liège, Liège, 4000, Belgium

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Gilles Darcis, MD PhD

    Liege University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 26, 2019

Study Start

October 1, 2019

Primary Completion

March 1, 2023

Study Completion

June 30, 2023

Last Updated

March 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

BE(1)