Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dolutegravir (DTG), Darunavir/Cobicistat (FDC).
- Who it may be relevant to
- Registry conditions: HIV, Insomnia, Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Dolutegravir (DTG)
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine - Drug Darunavir/Cobicistat (FDC)
Darunavir Cobicistat + TDF/FTC
Primary outcome measures
- Change in neuropsychiatric scales for Insomnia [Time frame: 12 weeks]
Secondary outcome measures (2)
- Discontinuation of ART due to Neuropsychiatric adverde effects [Time frame: 12 weeks]
- Risk factor associated with increase in neuropsychiatric scales [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06787976 · F-2024-3502-050