NCT03067285

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

September 8, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
Last Updated

February 5, 2020

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

February 14, 2017

Last Update Submit

February 3, 2020

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

  • To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.

    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale. anxiety and depression scale.

    Week 4

  • To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.

    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the pittsburgh sleep quality index.

    Week 4

  • To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.

    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the depression scale.

    Week 4

Secondary Outcomes (7)

  • To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF

    Week 4

  • To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF

    Week 4

  • To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF

    Week 4

  • To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF

    Week 24 after the switching

  • To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF

    Week 24 after the switching

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

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

Arm 2

EXPERIMENTAL

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

Drug: ELV/COBI/FTC/TAF

Interventions

ELV/COBI/FTC/TAFDRUG

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

Arm 2
DTG/3TC/ABC + ELV/COBI/FTC/TAFDRUG

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 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Fundación Jimenez Díaz

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Univ. Infanta Leonor

Madrid, Spain

Location

Hospital Univ. La Princesa

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A phase IV, open-label, randomised, pilot clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2017

First Posted

March 1, 2017

Study Start

September 8, 2017

Primary Completion

April 23, 2019

Study Completion

April 23, 2019

Last Updated

February 5, 2020

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(6)