Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05705349
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-01-20
Brief Title:
DORISL in HIV-1 Antiretroviral Treatment-naïve Participants MK-8591A-053
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Active-Controlled Double-Blind Clinical Study to Evaluate the Antiretroviral Activity Safety and Tolerability of DoravirineIslatravir DORISL 100 mg025 mg Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a randomized active-controlled double-blind clinical study designed to evaluate the antiretroviral activity safety and tolerability of doravirineislatravir DORISL MK-8591A in treatment-naïve participants with human immunodeficiency virus type 1 HIV-1 infection It is hypothesized that DORISL is non-inferior to bictegraviremtricitabinetenofovir alafenamide BICFTCTAF as assessed by the percentage of participants with HIV-1 ribonucleic acid RNA 50 copiesmL at Week 48
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031220720 | REGISTRY | jRCT | None |
| 2022-502099-22-00 | OTHER | None | None |