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

NCT06787976 | Not Yet Recruiting Phase 4

• 1 other identifier: F-2024-3502-050
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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).

Conditions

HIV; Insomnia; Anxiety

Keywords

INSTI; HIV; Dolutegravir; Darunavir; Suicide; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in neuropsychiatric scales for Insomnia

  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 Outcomes (2)

• Discontinuation of ART due to Neuropsychiatric adverde effects

  12 weeks

• Risk factor associated with increase in neuropsychiatric scales

  12 weeks

Study Arms (2)

DTG + TDF/FTC

EXPERIMENTAL

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

Drug: Dolutegravir (DTG)

DRV/c + TDF/FTC

ACTIVE COMPARATOR

Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine

Drug: Darunavir/Cobicistat (FDC)

Interventions

Dolutegravir (DTG) DRUG

Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

DTG + TDF/FTC

Darunavir/Cobicistat (FDC) DRUG

Darunavir Cobicistat + TDF/FTC

DRV/c + TDF/FTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Suicide; Depression

Interventions

dolutegravir; Darunavir; Cobicistat

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Central Study Contacts

Jose Antonio Mata Marin, Medical Doctor

CONTACT

52 644 1 560193; jamatamarin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label, randomized, clinical trial

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: January 22, 2025
• Study Start: June 19, 2025
• Primary Completion: December 21, 2025
• Study Completion: January 25, 2026
• Last Updated: June 26, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share