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Completed

NCT Number: NCT02042001

Switching From Efavirenz/Atripla to Rilpivirine Among Patients With Neurocognitive or Neuropsychological Side Effects

Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been associated with persistent central nervous system symptoms or mild or even asymptomatic neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric adverse events during EFV has not been explored yet.

The proposed pilot study will examine whether switching from single tablet regimen TDF/FTC/EFV to single tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement among HIV-infected patients with mild/asymptomatic neurocognitive impairment or neuropsychiatric symptoms during EFV-containing antiretroviral treatment.

Patients under stable treatment with TDF/FTC/EFV, confirmed HIV-1 RNA viral load < 50 copies/mL and altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or more domains as assessed by neuropsychological assessment, will be randomized to immediate or deferred (24 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will be repeated after 12, 24 and 48 weeks of follow-up and variations will be compared between groups.

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Key information

Conditions

Impaired Cognition Anxiety Disorders Behavior Behavioral Symptoms Cognition Disorders Depression Depression/Anxiety HIV-1 Infection Mental Disorders Neurocognitive Disorders Poor Quality Sleep Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinic of Infectious Diseases, AO San Gerardo, Monza, MB, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old and ability to sign informed consent
  • Continuative treatment with TDF/FTC/EFV for ≥180 days
  • HIV-1 RNA viral load < 50 copies/mL in two consecutive determinations (including screening)
  • No history of treatment failure and/or evidence of any mutations associated with resistance to NRTI or NNRTI
  • No contraindication to treatment with study drugs
  • Any one of the following conditions:

(i) Altered scores in depression, quality of sleep or anxiety tests (ii) Alteration in 1 or more domains as assessed by neuropsychological assessment

Exclusion criteria

  • Ongoing treatment or predictable need of treatment with proton pump inhibitors
  • New AIDS defining condition diagnosed within the 21 days prior to screening
  • Previous diagnosis of AIDS dementia complex
  • Current alcohol or substance dependence
  • Major psychiatric disorders
  • Decompensated cirrhosis
  • Plasma creatinine >1.2 mg/dl or estimated glomerular filtration rate <60 ml/min (MDRD formula)
  • AST, ALT or plasma bilirubin >3 times upper limit of normal
  • Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing/food requirements

Treatment and study plan

Immediate switch to TDF/FTC/RPV

Drug

Other names: Eviplera (r)

Switch to TDF/FTC/RPV after 24 weeks

Drug

Patients will continue current EFV-containing regimen up to week 24 and then will be switched to TDF/FTC/RPV

Other names: Eviplera(r)

Primary outcomes

  1. Neuropsychiatric side effects

    Time frame: 24 weeks

    Proportion of patients with improvement in depression, anxiety or quality of sleep scores, evaluated either as a binary (Yes/No) or on a continuous scale

  2. Neurocognitive side effects

    Time frame: 24 weeks

    • Proportion of patients with improvement in neurocognitive performances in either one of the 7 domains investigated, evaluated either as a binary (Abnormal/Normal) or on a continuous scale (deficit score)

  3. Composite neuropsychiatric/neurocognitive

    Time frame: 24 weeks

    Proportion of patients with improvement in either one of the previous binary end-point (composite end-point)

Secondary outcomes

  1. Symptoms

    Time frame: 24 weeks

    Proportion of patients with self-reported improvement in treatment-related symptoms

  2. Quality of Life

    Time frame: 24 weeks

    Proportion of patients with self-reported improvement in quality of life

  3. Cognitive failure

    Time frame: 24 weeks

    Proportion of patients with improvement in Cognitive Failure Questionnaire

  4. Viral suppression

    Time frame: 12 weeks

    Proportion of patients with HIV-RNA <50 copies/ml after 12 weeks of treatment (ITT-M=F)

  5. Viral failure

    Time frame: 12 weeks

    Proportion of patients with HIV-RNA <400 copies/ml after 12 weeks (ITT-M=F)

  6. Virological efficacy

    Time frame: 24 weeks

    Proportion of patients with HIV-RNA <50 copies/ml after 24 weeks (ITT-M=F)

  7. Safety & Tolerability

    Time frame: 24 weeks

    Proportion of patients discontinuing treatment for intolerance to study drugs or due to side effects

Other outcomes

  1. Resistance

    Time frame: 12 & 24 weeks

    Number of patients with genotypic resistance at failure

  2. Immunological response

    Time frame: 12 & 24 weeks

    Change From Baseline in CD4+ and CD8+ T-Lymphocyte Cell Counts at Weeks 12 and 24

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among Virologically Suppressed, HIV-1 Infected Subjects With Mild or Asymptomatic EFV-related Neurocognitive or Neuropsychological Side Effects

Acronym: SWEAR

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 22, 2014
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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