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

NCT06787976 — Phase 4, Unknown, 140 participants, Instituto Mexicano del Seguro Social

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06787976, acronym MORFEO
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, screening
Enrollment	140 (Estimated)
Sponsor	Instituto Mexicano del Seguro Social (Other gov)
Conditions	HIV, Insomnia, Anxiety
Interventions	Dolutegravir (DTG), Darunavir/Cobicistat (FDC) (Drug)
Dates	start 2025-06-19 (estimated), primary completion 2025-12-21 (estimated), completion 2026-01-25 (estimated), first posted 2025-01-22, last updated 2025-06-26

-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).

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
DTG + TDF/FTC	Experimental	Drug: Dolutegravir (DTG)	Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
DRV/c + TDF/FTC	Active comparator	Drug: Darunavir/Cobicistat (FDC)	Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine

Dolutegravir (DTG) (Drug): Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
Darunavir/Cobicistat (FDC) (Drug): Darunavir Cobicistat + TDF/FTC

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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.