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

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

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).

This clinical trial aims to evaluate changes in neuropsychiatric scale (NPS) scores among Mexican men living with HIV who present baseline NPS symptoms and are naïve to antiretroviral therapy (ART). Participants will initiate either a Dolutegravir (DTG)-based regimen or a Darunavir/Cobicistat (DRV/c)-based regimen, both combined with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). All patients will undergo a psychiatric evaluation prior to ART initiation. Treatment discontinuation will be considered for participants experiencing an exacerbation of NPS symptoms associated with grade ≥2 adverse events. NPS scores will be assessed and compared at weeks 4 and 12.

Inclusion Criteria:

• Patients living with HIV not experienced to ART
• Age ≥ 18 years.
• eGFR >60 mL/min
• Beneficiaries of the Mexican Social Security Institute treated at the "La Raza" National Medical Center
• Patients with a baseline ISI scale score: ≥8-14 points
• Patients with a baseline PHQ-9 scale score: 5-9 points
• Patients with a baseline HADS-A scale score: 8-10 points
• Patients with a baseline HADS-D scale score: 8-10 points
• Patients with a baseline Pittsburgh scale score: 5-7 points.

Exclusion Criteria:

• Patients with use of antidepressants/anxiolytics prior to starting ART
• Any Contraindication for the use of second generation INSTI or IP ART regimen
• Coinfection with Hepatitis C Virus
• Known resistance mutations to any of the components of both treatment regimens.