Clincosm LogoSign in Get a demo

IDOLTIB: Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

Sponsor
University of Liege (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04034862
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
44.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Treatment simplification (dolutegravir lamivudine)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2DR

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

Drug: Treatment simplification (dolutegravir lamivudine)
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen
No Intervention: 3DR

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

Outcome Measures

Primary Outcome Measures

  1. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues. [1 year]

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

Secondary Outcome Measures

  1. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia. [1 year]

  2. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation. [1 year]

  3. The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy. [1 year]

  4. The level of clonal expansion in the blood and tissue RCR [1 year]

  5. The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liège university hospital Liège Belgium 4000

Sponsors and Collaborators

  • University of Liege

Investigators

  • Principal Investigator: Gilles Darcis, MD PhD, Liege University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilles Darcis, Head of clinic, University of Liege
ClinicalTrials.gov Identifier:
NCT04034862
Other Study ID Numbers:
  • 13011987
First Posted:
Jul 26, 2019
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
HIV Infections
Lamivudine
Dolutegravir

Study Results

No Results Posted as of May 4, 2022