Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652700
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2020-12-02
Brief Title:
Oral Islatravir MK-8591 Once-Monthly as Preexposure Prophylaxis PrEP in Men and Transgender Women Who Are at High Risk for HIV-1 Infection MK-8591-024
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 Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men and Are at High Risk for HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Impower-024
Brief Summary:
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir ISL once monthly QM as Preexposure Prophylaxis PrEP in cisgender men who have sex with men MSM and transgender women TGW who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days
Detailed Description:
Based on laboratory findings of decreased lymphocyte and CD4 T-cell counts across the islatravir program dosing of blinded study intervention was halted on 13-Dec-2021 Blinded assessments conducted prior to then are designated as Study Part 1 During Study Part 2 participants from Part 1 were switched to PrEP therapy with emtricitabinetenofovir disoproxil FTCTDF or emtricitabinetenofovir alafenamide FTCTAF while continuing in the study In Part 3 participants investigators and all Sponsor personnel are unblinded to participants original randomized intervention group and participants may continue to receive unblinded FTCTDF or FTCTAF Screening and randomization of new participants have stopped with no new participants being enrolled in Part 2 or Part 3
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 |
|---|---|---|---|
| 2020-003309-79 | EUDRACT_NUMBER | jRCT | None |
| MK-8591-024 | OTHER | None | None |
| jRCT2031200419 | REGISTRY | None | None |