drugset / Trial / NCT06787976

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

NCT06787976

Phase 4 Not yet recruiting 140 enrolled Mexican Social Security Institute
RandomizedParallel-groupOpen-labelScreening

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).

Timeline

Start
2025-06-19
Primary completion
2025-12-21
Completion
2026-01-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darunavir/Cobicistat Unknown
Subject Dolutegravir Other / unclassified