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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Control | No Intervention | Group of patients without modification of baseline treatment (Triumeq: ABC/3TC/DTG). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir 50 MG | Drug | already included in arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the impact of DTG treatment intensification on residual viremia | Measurement of HIV viremia at the single copy level | 3 months |
| To evaluate the impact of DTG treatment intensification on immune activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liège university hospital | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41575190 | Derived | 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. |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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Measurement of T cell activation markers
| 3 months |
| To investigate the correlation between blood and tissues HIV reservoir | Measurement of blood and tissue HIV reservoir | 3 months |
| To correlate the concentration of DTG with residual viremia and impact on HIV reservoir | Measurement of DTG blood concentration | 3 months |
| To evaluate the impact of DTG treatment intensification on inflammation | Measurement on inflammatory markers in blood | 3 months |