Clinical Trials

MainTitle

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) (DETOX)

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2018 by Fundacion SEIMC-GESIDA

Sponsor
Fundacion SEIMC-GESIDA

Collaborator
Janssen-Cilag, S.A.

Information provided by (Responsible Party)
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier
NCT03685500

First received: September 8, 2018
Last updated: August 26, 2019
Last Verified: September 2018
History of Changes
Purpose

Purpose

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)

Condition Intervention Phase
HIV Infections

Drug : Symtuza® (TAF/FTC/DRV/c)
Drug : ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A phase IV, multicentre, randomised, open-label, pilot clinical trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide/Emtricitabine/Darunavir/Cobicistat

Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures

  • Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c [ Time Frame: week 4 ]
    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 (PSQI). The PSQI contains 19 questions in total. These questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates medium difficulty, within their respective area. The score of the seven areas is finally added for a global score, which ranges from 0 to 21 points. "0" indicates ease of sleep and "21" severe difficulty in all areas
Secondary Outcome Measures:
  • Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c [ Time Frame: week 4 ]
    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. Researchers will specifically ask the patient about eleven adverse effects at each visit. Each adverse effect will be documented and graduated, according to the criteria established in the "AIDS Clinical Trials Group (ACTG) Division of AIDS scale (2014)". Each adverse effect will be assigned a score between 0 and 3 points. The Score will include the individual scores for each of the eleven adverse effects collected, as well as the sum of all the individual scores presented by each patient at each study visit
  • Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c [ Time Frame: week 4 ]
    To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale. The scale includes 14 questions to evaluate the presence of depressive symptoms during the last week. Each question contains four answers with score between 0 and 3 points. To obtain the results of the questionnaire, the researcher must add the score obtained in the 7 questions of anxiety on the one hand and the 7 questions of depression on the other
  • Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c [ Time Frame: Week 4 and 8 after switching to TAF/FTC/DRV/c ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale
  • Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c [ Time Frame: Week 4 and 8 after switching to TAF/FTC/DRV/c ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the Pittsburg sleep quality index (PSQI)
  • Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c [ Time Frame: Week 4 and 8 after switching to TAF/FTC/DRV/c ]
    To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale.
  • Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c [ Time Frame: Week 8 after switching to TAF/FTC/DRV/c ]
    Virologic failure is defined as the presence of two consecutive HIV viral loads ≥ 50 copies/mL.

Estimated Enrollment: 110
Study Start Date: December 4, 2018
Estimated Study Completion Date: December 15, 2019
Estimated Primary Completion Date: December 15, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Arm 1
Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks
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

Experimental: Arm 2
Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit
Drug: Symtuza® (TAF/FTC/DRV/c)

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

Detailed Description:

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 100 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03685500

Locations

Spain
Hospital Puerta de Hierro Not yet recruiting
Majadahonda, Madrid, Spain
Contact: Alfonso Angel-Moreno Maroto    911 916 112    alfangel22@hotmail.com
Hospital Fundación Jimenez Diaz Recruiting
Madrid, Spain
Contact: Alfonso Cabello    915504800 ext 4055    acabello@fjd.es
Hospital Infanta Leonor Recruiting
Madrid, Spain
Contact: Jesus Troya, MD    911918281    jestrogar@hotmail.com
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Ignacio Perez valero, MD    0034917277000 ext 42132    ignacioperezvalero@gmail.com

Sponsors and Collaborators

Fundacion SEIMC-GESIDA
Janssen-Cilag, S.A.
More Information

More Information


Responsible Party: Fundacion SEIMC-GESIDA  
ClinicalTrials.gov Identifier: NCT03685500   History of Changes  
Other Study ID Numbers: GESIDA 10418  
Study First Received: September 8, 2018  
Last Updated: August 26, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Tenofovir
Lamivudine
Emtricitabine
Darunavir
Dolutegravir
Abacavir
Cobicistat

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.