Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified July 2019 by Gilles Darcis, University of Liege

Sponsor
University of Liege


Information provided by (Responsible Party)
Gilles Darcis, University of Liege

ClinicalTrials.gov Identifier
NCT04034862

First received: July 17, 2019
Last updated: July 24, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : Treatment simplification (dolutegravir lamivudine)
Phase 3

Study Type: Interventional
Study Design: 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)

Further study details as provided by Gilles Darcis, University of Liege:

Primary Outcome Measures

  • The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues. [ Time Frame: 1 year ]
    Measurements of RCR in the blood and tissues (rectal biopsies)
Secondary Outcome Measures:
  • The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia. [ Time Frame: 1 year ]
  • The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation. [ Time Frame: 1 year ]
  • The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy. [ Time Frame: 1 year ]
  • The level of clonal expansion in the blood and tissue RCR [ Time Frame: 1 year ]
  • The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation. [ Time Frame: 1 year ]

Estimated Enrollment: 40
Study Start Date: October 1, 2019
Estimated Study Completion Date: March 31, 2022
Estimated Primary Completion Date: April 1, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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)
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04034862

Contacts

Contact:   Gilles Darcis +3243667235 ext +3243667235 gdarcis@chuliege.be
Contact:   Michel Moutschen +3243667235 ext +3243667235 michel.moutschen@ulg.ac.be

Sponsors and Collaborators

University of Liege

Investigators

Principal Investigator: Gilles Darcis, MD PhD Liege University Hospital
More Information

More Information


Responsible Party: Gilles Darcis, Head of clinic, University of Liege  
ClinicalTrials.gov Identifier: NCT04034862   History of Changes  
Other Study ID Numbers: 13011987  
Study First Received: July 17, 2019  
Last Updated: July 24, 2019  
Individual Participant Data    
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

ClinicalTrials.gov processed this data on August 13, 2020
This information is provided by ClinicalTrials.gov.