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)

NCT03685500 | Completed Phase 4

• 1 other identifier: GESIDA 10418
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 6

Brief Summary

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)

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

  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

  week 4

Secondary Outcomes (6)

• 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

  week 4

• 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

  week 4

• Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c

  Week 4 and 8 after switching to TAF/FTC/DRV/c

• Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c

  Week 4 and 8 after switching to TAF/FTC/DRV/c

• Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c

  Week 4 and 8 after switching to TAF/FTC/DRV/c

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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)

Arm 2

EXPERIMENTAL

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

Drug: Symtuza® (TAF/FTC/DRV/c)

Interventions

Symtuza® (TAF/FTC/DRV/c) DRUG

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

Arm 2

ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c) 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 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

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 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

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead
• Janssen-Cilag, S.A.: collaborator

Study Sites (6)

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Univ. 12 de Octubre

Madrid, 28041, Spain

Location

H. Univ. Príncipe de Asturias

Madrid, Spain

Location

Hospital Fundación Jimenez Diaz

Madrid, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

symtuza

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: September 26, 2018
• Study Start: December 4, 2018
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)