Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

HIV Infections Clinical Trial

— IDOLTIB  

Official title:

Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04034862
• Other study ID #: 13011987
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Treatment simplification (dolutegravir lamivudine)
Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

Locations

Country	Name	City	State
Belgium	Liège university hospital	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.		1 year
Secondary	The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.		1 year
Secondary	The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.		1 year
Secondary	The level of clonal expansion in the blood and tissue RCR		1 year
Secondary	The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.		1 year