Clinical Trial

Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.

Study acronym: MORFEO
Not Yet Recruiting Phase 4
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Record status
This record was last updated June 26, 2025 (before its estimated December 21, 2025 completion). Its status may not reflect the trial's current state.
Summary
This clinical trial aimed at evaluating changes in neuropsychiatric scales for depression, anxiety, insomnia, and sleep quality in people living with HIV (PLHIV) who initiate antiretroviral therapy (ART) with a regimen of Dolutegravir (DTG) or Darunavir/Cobicistat (DRV/c), both combined with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-16.
Trial Details
NCT Number NCT06787976
Lead Sponsor Instituto Mexicano del Seguro Social
Conditions HIV, Insomnia, Anxiety
Enrollment 140 participants
Start Date 2025-06-19
Primary Completion 2025-12-21 (estimated)
Study Completion 2026-01-25 (estimated)
Updated on ClinicalTrials.gov 2025-06-26