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

June 21, 2025 updated by: José Antonio Mata Marín, Instituto Mexicano del Seguro Social

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jose Antonio Mata Marin, Medical Doctor
  • Phone Number: 52 644 1 560193
  • Email: jamatamarin@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTG + TDF/FTC
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
Drug: Dolutegravir (DTG)
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
Active Comparator: DRV/c + TDF/FTC
Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine
Drug: Darunavir/Cobicistat (FDC)
Darunavir Cobicistat + TDF/FTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neuropsychiatric scales for Insomnia
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discontinuation of ART due to Neuropsychiatric adverde effects
Time Frame: 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.
12 weeks
Risk factor associated with increase in neuropsychiatric scales
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 19, 2025

Primary Completion (Estimated)

December 21, 2025

Study Completion (Estimated)

January 25, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2024-3502-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Our institution does not allow us to share personal information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Dolutegravir (DTG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe