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

Primary Purpose

HIV Infections

Status
Active
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Treatment simplification (dolutegravir lamivudine)
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liège university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

2DR

3DR

Arm Description

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

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

Outcomes

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.
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.
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.
The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.
The level of clonal expansion in the blood and tissue RCR
The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.

Full Information

First Posted
July 17, 2019
Last Updated
April 27, 2022
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04034862
Brief Title
Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs
Acronym
IDOLTIB
Official Title
Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2DR
Arm Type
Experimental
Arm Description
Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)
Arm Title
3DR
Arm Type
No Intervention
Arm Description
Continued 3 drug regimen treatment (DTG+ABC+3TC)
Intervention Type
Drug
Intervention Name(s)
Treatment simplification (dolutegravir lamivudine)
Intervention Description
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen
Primary Outcome Measure Information:
Title
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.
Description
Measurements of RCR in the blood and tissues (rectal biopsies)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.
Time Frame
1 year
Title
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.
Time Frame
1 year
Title
The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.
Time Frame
1 year
Title
The level of clonal expansion in the blood and tissue RCR
Time Frame
1 year
Title
The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Darcis, MD PhD
Organizational Affiliation
Liege University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liège university hospital
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

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