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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2018-01-15

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Switch

Immediate switch to TDF/FTC/RPV

Group Type EXPERIMENTAL

Immediate switch to TDF/FTC/RPV

Intervention Type DRUG

Deferred Switch

Switch to TDF/FTC/RPV after 24 weeks

Group Type ACTIVE_COMPARATOR

Switch to TDF/FTC/RPV after 24 weeks

Intervention Type DRUG

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

Interventions

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Immediate switch to TDF/FTC/RPV

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Eviplera (r) Eviplera(r)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No