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

Azienda Ospedaliera San Gerardo di Monza

Status and phase: Completed; Phase 4

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

Treatments: Drug: Immediate switch to TDF/FTC/RPV; Drug: Switch to TDF/FTC/RPV after 24 weeks

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02042001

IN-IT-264-1331

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Immediate Switch

Experimental group

Description:

Immediate switch to TDF/FTC/RPV

Treatment:

Drug: Immediate switch to TDF/FTC/RPV

Deferred Switch

Active Comparator group

Description:

Switch to TDF/FTC/RPV after 24 weeks

Treatment:

Drug: Switch to TDF/FTC/RPV after 24 weeks