Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs (IDOLTIB)
Verified July 2019 by Gilles Darcis, University of Liege
University of Liege
Information provided by (Responsible Party)
Gilles Darcis, University of Liege
First received: July 17, 2019
Last updated: July 24, 2019
Last Verified: July 2019
History of Changes
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.
Drug : Treatment simplification (dolutegravir lamivudine)
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)
- 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 ]
|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)|
Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)
Treatment simplification (dolutegravir lamivudine)
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen
Continued 3 drug regimen treatment (DTG+ABC+3TC)
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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 LocationsChoosing 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
|Contact: Gilles Darcis||+3243667235 ext +firstname.lastname@example.org|
|Contact: Michel Moutschen||+3243667235 ext +email@example.com|
Sponsors and CollaboratorsUniversity of Liege
|Principal Investigator:||Gilles Darcis, MD PhD||Liege University Hospital|
|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:
ClinicalTrials.gov processed this data on August 13, 2020
This information is provided by ClinicalTrials.gov.