Clinical trial NCT04034862: Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs
Official title: Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.
timeFrame: 1 year
Secondary outcomes:
measure: The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.
timeFrame: 1 year
measure: The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.
timeFrame: 1 year
measure: The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.
timeFrame: 1 year
measure: The level of clonal expansion in the blood and tissue RCR
timeFrame: 1 year
measure: The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Liège university hospital
Study officials:
affiliation: Liege University Hospital
name: Gilles Darcis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: