HIVPhase 4MORFEONCT06787976
Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.
A Phase 4 study testing Dolutegravir (DTG) and Darunavir/Cobicistat (FDC) in people with HIV and Insomnia, run by Instituto Mexicano del Seguro Social.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Dolutegravir (DTG) and Darunavir/Cobicistat (FDC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2025to 25 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
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).
Read the 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.
- Being tested
- Dolutegravir (DTG), Darunavir/Cobicistat (FDC)
- Keywords
- INSTI, HIV, Dolutegravir, Darunavir, Suicide, Depression, Anxiety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir (DTG)Drug
Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine
Darunavir/Cobicistat (FDC)Drug
Darunavir Cobicistat + TDF/FTC
| Study group | Role | What they receive |
|---|---|---|
| DTG + TDF/FTC | Experimental | Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine Receives: Drug: Dolutegravir (DTG) |
| DRV/c + TDF/FTC | Active comparator | Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine Receives: Drug: Darunavir/Cobicistat (FDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start19 Jun 2025 (estimated)
- Primary completion21 Dec 2025 (estimated)
- Study completion25 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomized, clinical trial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, José Antonio Mata Marín, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787976
- Sponsor's protocol ID
- F-2024-3502-050
- Acronym
- MORFEO
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our institution does not allow us to share personal information
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06787976
- Acronym / sponsor ID
- MORFEO / F-2024-3502-050
- Keywords
- INSTI, HIV, Dolutegravir, Darunavir, Suicide, Depression, Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 19 Jun 2025 (estimated)
- Primary completion
- 21 Dec 2025 (estimated)
- Study completion
- 25 Jan 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized, clinical trial
| Arm | Type | Receives |
|---|---|---|
| DTG + TDF/FTC | Experimental | Drug: Dolutegravir (DTG)Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine |
| DRV/c + TDF/FTC | Active comparator | Drug: Darunavir/Cobicistat (FDC)Darunavir/Cobicistat + Tenofovir Disoproxil Fumarate / Emtricitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir (DTG)Dolutegravir + Tenofovir Disoproxil Fumarate / Emtricitabine | Drug | DTG + TDF/FTC |
| Darunavir/Cobicistat (FDC)Darunavir Cobicistat + TDF/FTC | Drug | DRV/c + TDF/FTC |
Primary outcome
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.
2 secondary outcomes
Discontinuation of ART due to Neuropsychiatric adverde effects
Time frame: 12 weeks
Risk factor associated with increase in neuropsychiatric scales
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. Our institution does not allow us to share personal information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir (DTG) and Darunavir/Cobicistat (FDC) in people with HIV and Insomnia, run by Instituto Mexicano del Seguro Social.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Antonio Mata Marin, Medical Doctor (52 644 1 560193, jamatamarin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropsychiatric scales for Insomnia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.