Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04051970
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2019-07-26
Brief Title:
Reducing Antiretroviral Treatments
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Randomized Open-label Phase III Trial Comparing a Dual Nucleoside Analogues Strategy Preceded by a Triple Therapy Induction Period to an Immediate Strategy With Dolutegravir Plus Lamivudine in Antiretriviral naïve People Living With HIV With Viral Load 50000 cpmL and CD4 Cells 300mm3
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_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:
ALTAR
Brief Summary:
The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir TDF or tenofovir alafenamide TAF plus emtricitabine FTC or lamivudine 3TC preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor INI relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy ARV naïve participants with CD4 cells count greater than 300mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cpmL
Detailed Description:
ANRS 173 ALTAR is a multicenter comparative international open label phase III randomized trial aiming at evaluating the non-inferiority of a TRI-BI tritherapy-bitherapy strategy includes a 16 week - induction phase with 2 NRTI and a once daily integrase inhibitor followed by a bitherapy with TDF or TAF XTC in its capacity to achieve viral suppression at week 48 versus immediate BI bitherapy strategy DTG3TC in participants naïve to antiretroviral therapy with plasma HIV RNA strictly less than 50 000 copiesmL and CD4 cells count above 300mm3
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None