Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2DR | Experimental | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment simplification (dolutegravir lamivudine) | Drug | Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia. | 1 year | |
| The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilles Darcis, MD PhD | Liege University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liège university hospital | Liège | Liège | 4000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy. | 1 year |
| The level of clonal expansion in the blood and tissue RCR | 1 year |
| The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation. | 1 year |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |