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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 140
- Primary Endpoint
- Change in neuropsychiatric scales for Insomnia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
DTG + TDF/FTC
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
Intervention: Dolutegravir (DTG) (Drug)
DRV/c + TDF/FTC
Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine
Intervention: Darunavir/Cobicistat (FDC) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Discontinuation of ART due to Neuropsychiatric adverde effects(12 weeks)
- Risk factor associated with increase in neuropsychiatric scales(12 weeks)
Investigators
José Antonio Mata Marín
Principal Investigator
Instituto Mexicano del Seguro Social