Clinical trial NCT06787976: Effect of Dolutegravir Compared with Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects Al 12 Weeks in Antirretroviral Treatment-Naive Adults.
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HIV
Insomnia
Anxiety
Keywords: INSTI
HIV
Dolutegravir
Darunavir
Suicide
Depression
Anxiety
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomized, clinical trial
Primary purpose: SCREENING

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.

Eligibility 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.

Primary outcomes:
measure: Change in neuropsychiatric scales for Insomnia
timeFrame: 12 weeks
Secondary outcomes:
measure: Discontinuation of ART due to Neuropsychiatric adverde effects
timeFrame: 12 weeks
measure: Risk factor associated with increase in neuropsychiatric scales
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: