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

NCT ID: NCT06787976

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-19
• Study Completion Date: 2026-01-25

Brief 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).

Detailed 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.

Conditions

HIV; Insomnia; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

DTG + TDF/FTC

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

Group Type: EXPERIMENTAL

Dolutegravir (DTG)

Intervention Type: DRUG

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

DRV/c + TDF/FTC

Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine

Group Type: ACTIVE_COMPARATOR

Darunavir/Cobicistat (FDC)

Intervention Type: DRUG

Darunavir Cobicistat + TDF/FTC

Interventions

Dolutegravir (DTG)

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

Intervention Type: DRUG

Darunavir/Cobicistat (FDC)

Darunavir Cobicistat + TDF/FTC

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: lead

Responsible Party

José Antonio Mata Marín

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jose Antonio Mata Marin, Medical Doctor

Role: CONTACT

jamatamarin@gmail.com

52 644 1 560193

Other Identifiers

F-2024-3502-050

Identifier Type: -

Identifier Source: org_study_id