A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-08

Study Completion Date

2019-04-23

Brief Summary

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A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.

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Detailed Description

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we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A phase IV, open-label, randomised, pilot clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Patients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks:

Group Type ACTIVE_COMPARATOR

DTG/3TC/ABC + ELV/COBI/FTC/TAF

Intervention Type DRUG

Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks

Arm 2

Patients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit

Group Type EXPERIMENTAL

ELV/COBI/FTC/TAF

Intervention Type DRUG

Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.

Interventions

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ELV/COBI/FTC/TAF

Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.

Intervention Type DRUG

DTG/3TC/ABC + ELV/COBI/FTC/TAF

Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient \> 18 years of age diagnosed with HIV using normal serology techniques.
* Current antiretroviral therapy with DTG/3TC/ABC.
* HIV viral load \< 50 copies/mL for at least 12 weeks prior to signing the consent form \[(\]confirmed by two assays at least 12 weeks apart with viremia \< 50 copies/mL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
* Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:

* Symptoms of anxiety or depression
* Insomnia or other sleep disturbances
* Headache
* Cognitive complaints (attention, concentration or memory)
* Alterations in behaviour (irritability, aggressiveness or agitation)
* Dizziness of neurological or neurologically-mediated origin

Exclusion Criteria

* Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
* Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
* History of active CNS infections
* Active psychosis, major depression with psychotic symptoms or autolytic ideation
* Dementia or mental retardation
* Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria
* Illnesses that may interfere with the study procedures
* Claustrophobia
* Presence of magnetisable devices in the body
* Inability to complete any of the study procedures
* Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No