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

ConditionsHIVInsomniaAnxiety
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dolutegravir (DTG)

    Drug

    Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine

  • Darunavir/Cobicistat (FDC)

    Drug

    Darunavir Cobicistat + TDF/FTC

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: DTG + TDF/FTCExperimental treatment 1 intervention
Group B: DRV/c + TDF/FTCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in neuropsychiatric scales for Insomnia

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.

Time frame
12 weeks

Secondary outcomes

1

Discontinuation of ART due to Neuropsychiatric adverde effects

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.

Time frame
12 weeks
2

Risk factor associated with increase in neuropsychiatric scales

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.

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Mexicano del Seguro Social

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: