Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-27 @ 6:00 AM
Study NCT ID:
NCT04979468
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)
Sponsor:
Societa' Italiana Di Malattie Infettive E Tropicali
Organization:
Study Overview
Official Title:
Efficacy and Safety of Early Switching to Dolutegravir/Lamivudine (DTG/3TC) From INSTI-based Three-drug Regimens in HIV-1-infected Adults Previously naïve Who Achieve Virological Suppression
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EDOLAS
Brief Summary:
Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA \<50 copies/mL
Detailed Description:
The target population of this study is HIV-1-infected adults without previous virological failure, currently receiving any first-line, triple-drug ART having an INSTI (EVG/cobi, RAL QD, DTG, BIC) as anchor drug associated to any of the following dual NRTI backbone (ABC/3TC, TDF/FTC or TAF/FTC) with virological suppression (HIV-1 RNA \< 50 copies/mL).
Participants will be randomly allocated 1:1 to switch to DTG/3TC 50/300 mg as a single pill qd until week 96 (Arm A, early switch) or to continue their INSTI-based ART triple regimen received at screening (Arm B, delayed switch) until week 52, when participants in Arm B with HIV-1 RNA\< 50 cp/mL at week 48 will switch to DTG/3TC 50/300 mg qd as a single pill until week 100.
The drugs of both arms will be administered in an open-label manner throughout the entire duration of the study.
The primary analysis will take place after the last participant completes 52 weeks on therapy, to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 cp/mL at the Week 48 visit.
If the second determination of HIV-1 RNA is \<50 cp/mL, then the participant has not a virological rebound and will be considered eligible to switch to DTG/3TC at Week 52.
If the second determination of HIV-1 RNA is ≥50 cp/mL, then the participant will be considered protocol-defined virological failure, thus being ineligible to switch to DTG/ 3TC. These participants will be withdrawn from the study.
A preliminary interim analysis will be performed after 50% of the enrolled participants have reached the 24th week of study, always considering 4 weeks more (thus 28 weeks) to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 copies/mL at Week 24.
At week 48, participants in Arm A (early switch) will continue DTG/3TC. At week 52, participants in Arm B (delayed switch) and with HIV-1 RNA \< 50 copies/mL at week 48 will switch to DTG/3TC and will be followed until week 100.
The exploratory analyses at Week 96 will take place after the last participant completes 100 weeks on therapy, as needed, to allow for the collection of a confirmatory viral load measurement in participants presenting with HIV-1 RNA ≥50 copies/mL at Week 96.
Participants will be randomly allocated 1:1 to switch to DTG/3TC 50/300 mg as a single pill qd until week 96 (Arm A, early switch) or to continue their INSTI-based ART triple regimen received at screening (Arm B, delayed switch) until week 52, when participants in Arm B with HIV-1 RNA\< 50 cp/mL at week 48 will switch to DTG/3TC 50/300 mg qd as a single pill until week 100.
The drugs of both arms will be administered in an open-label manner throughout the entire duration of the study.
The primary analysis will take place after the last participant completes 52 weeks on therapy, to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 cp/mL at the Week 48 visit.
If the second determination of HIV-1 RNA is \<50 cp/mL, then the participant has not a virological rebound and will be considered eligible to switch to DTG/3TC at Week 52.
If the second determination of HIV-1 RNA is ≥50 cp/mL, then the participant will be considered protocol-defined virological failure, thus being ineligible to switch to DTG/ 3TC. These participants will be withdrawn from the study.
A preliminary interim analysis will be performed after 50% of the enrolled participants have reached the 24th week of study, always considering 4 weeks more (thus 28 weeks) to allow for the collection of a confirmatory viral load measurement in participants possibly presenting with HIV-1 RNA ≥50 copies/mL at Week 24.
At week 48, participants in Arm A (early switch) will continue DTG/3TC. At week 52, participants in Arm B (delayed switch) and with HIV-1 RNA \< 50 copies/mL at week 48 will switch to DTG/3TC and will be followed until week 100.
The exploratory analyses at Week 96 will take place after the last participant completes 100 weeks on therapy, as needed, to allow for the collection of a confirmatory viral load measurement in participants presenting with HIV-1 RNA ≥50 copies/mL at Week 96.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: