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

Phase 4

Not yet recruiting

• Conditions: HIV; Insomnia; Anxiety
• Interventions: Drug: Dolutegravir (DTG); Drug: Darunavir/Cobicistat (FDC)

• Registration Number: NCT06787976
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Study Start: 2025-04-19
• Primary Completion: 2025-05-21
• Study Completion: 2025-09-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DTG + TDF/FTC	Dolutegravir (DTG)	Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
DRV/c + TDF/FTC	Darunavir/Cobicistat (FDC)	Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine

Primary Outcome Measures

Name	Time	Method
Change in neuropsychiatric scales for Insomnia	12 weeks	Change in scales evaluating the severity of neuropsychiatric effects (Insomnia Severity Index (ISI) in patients living with HIV who are naïve to antiretroviral therapy who initiate therapy with Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine compared to Darunavir/cobicistat + Tenofovir Disoproxil Fumarate/Emtricitabine at 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Discontinuation of ART due to Neuropsychiatric adverde effects	12 weeks	Number of patient discontinuation of ART in patients living with HIV who are naïve to antiretroviral therapy who start therapy with Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine compared to Darunavir/cobicistat + Tenofovir Disoproxil Fumarate/Emtricitabine after 12 weeks of treatment due to neuropsychiatric.
Risk factor associated with increase in neuropsychiatric scales	12 weeks	Identify the risk factors associated with the change in neuropsychiatric scales in patients living with HIV who are naïve to antiretroviral therapy and who initiate therapy with Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine compared to Darunavir/cobicistat + Tenofovir Disoproxil Fumarate/Emtricitabine at 12 weeks of treatment.