A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c)

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-06-25

Brief Summary

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A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)

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Detailed Description

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The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks

Group Type ACTIVE_COMPARATOR

ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)

Intervention Type DRUG

Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks

Arm 2

Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit

Group Type EXPERIMENTAL

Symtuza® (TAF/FTC/DRV/c)

Intervention Type DRUG

Treatment with TAF/FTC/DRV/c during 8 weeks since randomized

Interventions

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Symtuza® (TAF/FTC/DRV/c)

Treatment with TAF/FTC/DRV/c during 8 weeks since randomized

Intervention Type DRUG

ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)

Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient ≥ 18 years of age diagnosed with HIV using conventional serology techniques.
* Current antiretroviral therapy with ABC/3TC/DTG for at least 4 weeks.
* HIV viral load \< 50 copies/mL for at least 24 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.
* A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).

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 TAF/FTC/DRV/c.
* 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.
* 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.
* Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical data sheet

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No