Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06787976 | NOT YET RECRUITING | HIV

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

Mexican Social Security Institute

Information provided by (Responsible Party):

José Antonio Mata Marín

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).

Condition or disease

HIV

Insomnia

Anxiety

Intervention/treatment

Dolutegravir (DTG)

Darunavir/Cobicistat (FDC)

Phase

PHASE4

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
Estimated Enrollment : 140 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : 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
Actual Study Start Date : 2025-04-19
Estimated Primary Completion Date : 2025-05-21
Estimated Study Completion Date : 2025-09-25

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Effect of Dolutegravir Compared with Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects Al 12 Weeks in Antirretroviral Treatment-Naive Adults.

Location Details

NCT06787976

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found