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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Switch | Experimental | Immediate switch to TDF/FTC/RPV |
|
| Deferred Switch | Active Comparator | Switch to TDF/FTC/RPV after 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate switch to TDF/FTC/RPV | Drug |
|
| |
| Switch to TDF/FTC/RPV after 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric side effects | 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 | 24 weeks |
| Neurocognitive side effects | - 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) | 24 weeks |
| Composite neuropsychiatric/neurocognitive | Proportion of patients with improvement in either one of the previous binary end-point (composite end-point) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Proportion of patients with self-reported improvement in treatment-related symptoms | 24 weeks |
| Quality of Life | Proportion of patients with self-reported improvement in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Resistance | Number of patients with genotypic resistance at failure | 12 & 24 weeks |
| Immunological response | Change From Baseline in CD4+ and CD8+ T-Lymphocyte Cell Counts at Weeks 12 and 24 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Lapadula, MD, PhD | AO San Gerardo of Monza | Principal Investigator |
| Andrea Gori, MD | AO San Gerardo of Monza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Infectious Diseases, AO San Gerardo | Monza | MB | 20900 | Italy | ||
| Spedali Civili - University of Brescia |
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| Drug |
Patients will continue current EFV-containing regimen up to week 24 and then will be switched to TDF/FTC/RPV |
|
|
| 24 weeks |
| Cognitive failure | Proportion of patients with improvement in Cognitive Failure Questionnaire | 24 weeks |
| Viral suppression | Proportion of patients with HIV-RNA <50 copies/ml after 12 weeks of treatment (ITT-M=F) | 12 weeks |
| Viral failure | Proportion of patients with HIV-RNA <400 copies/ml after 12 weeks (ITT-M=F) | 12 weeks |
| Virological efficacy | Proportion of patients with HIV-RNA <50 copies/ml after 24 weeks (ITT-M=F) | 24 weeks |
| Safety & Tolerability | Proportion of patients discontinuing treatment for intolerance to study drugs or due to side effects | 24 weeks |
| 12 & 24 weeks |
| Brescia |
| Italy |
| Clinica di Malattie Infettive, Ospedale San Martino | Genova | Italy |
| AO San Paolo - University of Milan | Milan | Italy |
| Ospedale Amedeo di Savoia - University of Turin | Torino | Italy |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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