Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Mexicano del Seguro Social

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dolutegravir (DTG)
  • Darunavir/Cobicistat (FDC)

Treatment groups

140 Participants
are divided into 2 treatment groups

Locations

This trial has no locations