HIV InfectionsPhase 3IDOLTIBNCT04034862
Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs
A Phase 3 study testing Treatment simplification (dolutegravir lamivudine) in people with HIV Infections, run by University of Liege at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Treatment simplification (dolutegravir lamivudine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2019to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
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.
- Conditions
- HIV Infections
- Being tested
- Treatment simplification (dolutegravir lamivudine)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment simplification (dolutegravir lamivudine)Drug
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen
| Study group | Role | What they receive |
|---|---|---|
| 2DR | Experimental | Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC) Receives: Drug: Treatment simplification (dolutegravir lamivudine) |
| 3DR | No intervention | Continued 3 drug regimen treatment (DTG+ABC+3TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (5)
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.
Measured: 1 year
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.
Measured: 1 year
The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.
Measured: 1 year
The level of clonal expansion in the blood and tissue RCR
Measured: 1 year
The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Oct 2019
- Primary completion1 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilles Darcis, University of Liege
- Investigators
- Gilles Darcis, MD PhD, Principal investigator, Liege University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034862
- Sponsor's protocol ID
- 13011987
- Acronym
- IDOLTIB
- Status last verified
- Jan 2025
- First submitted
- 17 Jul 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
- ClinicalTrials.gov ID
- NCT04034862
- Acronym / sponsor ID
- IDOLTIB / 13011987
- Conditions
- HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2DR | Experimental | Drug: Treatment simplification (dolutegravir lamivudine)Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC) |
| 3DR | No intervention | –Continued 3 drug regimen treatment (DTG+ABC+3TC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment simplification (dolutegravir lamivudine)Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen | Drug | 2DR |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Darcis, MD PhD principal investigator
Liege University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment simplification (dolutegravir lamivudine) in people with HIV Infections, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.