HIV Infections
Conditions
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.
Interventions
DRUGTreatment simplification (dolutegravir lamivudine)
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues. | 1 year | Measurements of RCR in the blood and tissues (rectal biopsies) |
Secondary
| Measure | 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 |
| 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 |
Countries
Belgium
Outcome results
None listed