HIV, Insomnia, Anxiety
Conditions
Keywords
INSTI, HIV, Dolutegravir, Darunavir, Suicide, Depression, Anxiety
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.
Interventions
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
Darunavir Cobicistat + TDF/FTC
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Open-label, randomized, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in neuropsychiatric scales for Insomnia | 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
| Measure | Time frame | Description |
|---|---|---|
| Discontinuation of ART due to Neuropsychiatric adverde effects | 12 weeks | Number of patient discontinuation of ART in patients living with HIV who are naïve to antiretroviral therapy who start therapy with Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine compared to Darunavir/cobicistat + Tenofovir Disoproxil Fumarate/Emtricitabine after 12 weeks of treatment due to neuropsychiatric. |
| Risk factor associated with increase in neuropsychiatric scales | 12 weeks | Identify the risk factors associated with the change in neuropsychiatric scales in patients living with HIV who are naïve to antiretroviral therapy and who initiate therapy with Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine compared to Darunavir/cobicistat + Tenofovir Disoproxil Fumarate/Emtricitabine at 12 weeks of treatment. |
Contacts
Primary ContactJose Antonio Mata Marin, Medical Doctor
Outcome results
None listed