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

NCT02042001 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2018-07-05

No results posted yet for this study

Summary

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.

Conditions

  • Impaired Cognition
  • Depression/Anxiety
  • Poor Quality Sleep
  • Quality of Life
  • HIV-1 Infection

Interventions

DRUG

Immediate switch to TDF/FTC/RPV

DRUG

Switch to TDF/FTC/RPV after 24 weeks

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Azienda Ospedaliera San Gerardo di Monza

    lead OTHER

Principal Investigators

  • Giuseppe Lapadula, MD, PhD · AO San Gerardo of Monza

  • Andrea Gori, MD · AO San Gerardo of Monza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2017-07-03
Completion
2018-01-15

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042001 on ClinicalTrials.gov