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

Instituto Mexicano del Seguro Social

Status and phase: Not yet enrolling; Phase 4

Conditions: HIV; Insomnia; Anxiety

Treatments: Drug: Darunavir/Cobicistat (FDC); Drug: Dolutegravir (DTG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06787976

F-2024-3502-050

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

DTG + TDF/FTC

Experimental group

Description:

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

Treatment:

Drug: Dolutegravir (DTG)

DRV/c + TDF/FTC

Active Comparator group

Description:

Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine

Treatment:

Drug: Darunavir/Cobicistat (FDC)