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NOT YET RECRUITING
NCT06787976
PHASE4

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

Sponsor: Instituto Mexicano del Seguro Social

View on ClinicalTrials.gov

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).

Official title: Effect of Dolutegravir + Tenofovir Disoproxil Fumarato/Emtricitabina Compared With Darunavir/Cobicistat + Tenofovir Disoproxil/Fumarato /Emtricitabina on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults With HIV-1 Infection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-06-19

Completion Date

2026-01-25

Last Updated

2025-06-26

Healthy Volunteers

No

Interventions

DRUG

Dolutegravir (DTG)

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

DRUG

Darunavir/Cobicistat (FDC)

Darunavir Cobicistat + TDF/FTC