HIV-1-infectionPhase 2EDITNCT05351684
Effect of Dolutegravir Intensification on HIV-1 Reservoirs
A Phase 2 study testing Dolutegravir 50 MG in people with HIV-1-infection, run by University of Liege at 1 site in Belgium.
Trial summary
Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dolutegravir 50 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2019to 13 Dec 2022
- Phase
- Phase 2
- 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 3 years
- Undetectable viral for at least 3 years
- DTG/3TC/ABC as cART regimen in the previous 6 months.
- CD4 counts higher than 200 cells per μL
Who cannot join
- active hepatitis C or B
- 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 10Show fewer
- hospitalization for acute illness within the previous 8 weeks
- Pregnancy or breastfeeding.
- 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: Effect of Dolutegravir Intensification on Blood and Tissue Latent HIV-1 Reservoirs and on Residual Viremia Despite ART
Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal.
The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.
- Conditions
- HIV-1-infection
- Being tested
- Dolutegravir 50 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 50 MGDrug
already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Intensified | Experimental | Group of patients whose treatment will be intensified with an additional 50mg of dolutegravir on top of regular treatment (Triumeq: ABC/3TC/DTG). Receives: Drug: Dolutegravir 50 MG |
| Control | No intervention | Group of patients without modification of baseline treatment (Triumeq: ABC/3TC/DTG). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues.
Measurements of blood and tissue HIV reservoir
Measured: 3 months
Secondary outcomes (5)
To evaluate the impact of DTG treatment intensification on residual viremia
Measurement of HIV viremia at the single copy level
Measured: 3 months
To evaluate the impact of DTG treatment intensification on immune activation
Measurement of T cell activation markers
Measured: 3 months
To investigate the correlation between blood and tissues HIV reservoir
Measurement of blood and tissue HIV reservoir
Measured: 3 months
To correlate the concentration of DTG with residual viremia and impact on HIV reservoir
Measurement of DTG blood concentration
Measured: 3 months
To evaluate the impact of DTG treatment intensification on inflammation
Measurement on inflammatory markers in blood
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jan 2019
- Primary completion28 Aug 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351684
- Sponsor's protocol ID
- 2018-228
- Acronym
- EDIT
- Status last verified
- Dec 2022
- First submitted
- 24 Oct 2019
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fombellida-Lopez C, Valaitiene A, Winchester L, Maes N, Dellot P, Vanwinge C, Ladang A, Cavalier E, Susin F, Vaira D, Hayette MP, Reenaers C, Moutschen M, Fletcher CV, Pasternak AO, Darcis G. Doubling dolutegravir dosage reduces the viral reservoir in ART-treated people with HIV. Elife. 2026 Jan 23;14:RP106931. doi: 10.7554/eLife.106931.
PubMed 41575190
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dolutegravir Intensification on Blood and Tissue Latent HIV-1 Reservoirs and on Residual Viremia Despite ART
- ClinicalTrials.gov ID
- NCT05351684
- Acronym / sponsor ID
- EDIT / 2018-228
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 28 Apr 2022 (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.
Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal.
The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified | Experimental | Drug: Dolutegravir 50 MGGroup of patients whose treatment will be intensified with an additional 50mg of dolutegravir on top of regular treatment (Triumeq: ABC/3TC/DTG). |
| Control | No intervention | –Group of patients without modification of baseline treatment (Triumeq: ABC/3TC/DTG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-infected adults receiving cART for at least 3 years
- Undetectable viral for at least 3 years
- DTG/3TC/ABC as cART regimen in the previous 6 months.
- CD4 counts higher than 200 cells per μL
Key exclusion criteria (10 listed)
- active hepatitis C or B
- 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 |
|---|---|---|
| Dolutegravir 50 MGalready included in arm/group descriptions. | Drug | Intensified |
Primary outcome
To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues.
Time frame: 3 months
Measurements of blood and tissue HIV reservoir
5 secondary outcomes
To evaluate the impact of DTG treatment intensification on residual viremia
Time frame: 3 months
To evaluate the impact of DTG treatment intensification on immune activation
Time frame: 3 months
To investigate the correlation between blood and tissues HIV reservoir
Time frame: 3 months
To correlate the concentration of DTG with residual viremia and impact on HIV reservoir
Time frame: 3 months
To evaluate the impact of DTG treatment intensification on inflammation
Time frame: 3 months
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 15 Dec 2022.
- Derived from this study: PubMed 41575190Fombellida-Lopez C, Valaitiene A, Winchester L, Maes N, Dellot P, Vanwinge C, Ladang A, Cavalier E, Susin F, Vaira D, Hayette MP, Reenaers C, Moutschen M, Fletcher CV, Pasternak AO, Darcis G. Doubling dolutegravir dosage reduces the viral reservoir in ART-treated people with HIV. Elife. 2026 Jan 23;14:RP106931. doi: 10.7554/eLife.106931.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dolutegravir 50 MG in people with HIV-1-infection, 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 4 inclusion and 10 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 15 Dec 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351684, which also lists 1 linked publication.
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 15 Dec 2022.