Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-06
Brief Title:
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Phase III Open-label Randomized Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
ELDORADO
Brief Summary:
Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection
Detailed Description:
Phase III multicenter open-label randomized non-inferiority clinical trial which aims to assess the non-inferiority of doravirine in association with tenofovir and lamivudine as compared to dolutegravir in association with tenofovir and lamivudine or emtricitabine
This trial will be implemented in Brazil Cambodia Cameroon Côte dIvoire France and Mozambique
Six hundred and ten patients will be enrolled and followed for 96 weeks after entry in the trial ART initiation
Primary endpoint will assess virological efficacy at Week 48 measured by the proportion of subjects achieving HIV-1 RNA 50 copiesmL in HIV-1 infected treatment-naive subjects with pre-treatment viral load HIV-1 RNA 1000 copiesmL
Secondary endpoints are planned at W48 and W96
This trial will be implemented in Brazil Cambodia Cameroon Côte dIvoire France and Mozambique
Six hundred and ten patients will be enrolled and followed for 96 weeks after entry in the trial ART initiation
Primary endpoint will assess virological efficacy at Week 48 measured by the proportion of subjects achieving HIV-1 RNA 50 copiesmL in HIV-1 infected treatment-naive subjects with pre-treatment viral load HIV-1 RNA 1000 copiesmL
Secondary endpoints are planned at W48 and W96
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?:
False
Is an FDA AA801 Violation?:
None