HIV
Conditions
Interventions
Trade Name: Eviplera
Product Name: Eviplera (tenofovir/emtricitabine/rilpivirine)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tenofovir
Concentration unit: mg milligram(s)
Concentrati
Sponsors
St Stephen's AIDS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Is male or female aged 18 years or above - Has HIV-1 infection documented in their medical notes - Has signed the Informed Consent Form voluntarily - Is willing to comply with the protocol requirements - Has been on Atripla for at least 12 weeks OR Kivexa plus efavirenz - Has an HIV-plasma viral load at screening 50 cells/mm3 - Estimated glomerular filtration rate (MDRD) >50 ml/min. - Has symptomatic CNS related toxicity associated with EFV - If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential - If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Infected with HIV-2 - Using any concomitant therapy disallowed as per SPC for the study drugs (note acid-reducing agents and interaction with rilpivirine) - Has acute viral hepatitis including, but not limited to, A, B, or C - Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Subjects can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period. - Any investigational drug within 30 days prior to the trial drug administration - Has received rilpivirine in the past - Any clinical evidence of baseline resistance mutations - Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption - Severe hepatic impairment - Moderate or severe renal impairment (creatinine clearance < 50ml/min) - If female, she is pregnant or breastfeeding - Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed). - Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether switching individuals who have central nervous system (CNS) side effects from taking efavirenz-containing treatment (as Atripla or Kivexa plus efavarinz) to Eviplera resolves the CNS side effects after 12 weeks.;Secondary Objective: - To investigate whether switching individuals who have central nervous system (CNS) side effects from taking efavirenz-containing treatment to Eviplera resolves the CNS side effects after 24 weeks. - To investigate the impact of switching to Eviplera from an efavirenz-containing treatment on quality of sleep over 24 weeks - To investigate the change in CD4 count in individuals switching to Eviplera from an efavirenz-containing treatment over 24 weeks - To investigate continued virus suppression in individuals switching to Eviplera from an efavirenz-containing treatment over 24 weeks - To investigate changes in fasting lipids- cholesterol and triglycerides- in individuals switching to Eviplera from an efavirenz-containing treatment over 24 weeks - To investigate the safety of switching to Eviplera from an efavirenz-containing treatment over 24 weeks - To investigate the impact of switching to Eviplera from an efavirenz-containing treatment on drug adherence over 24 weeks - To ;Primary end point(s): The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) after 12 weeks of tenofovir/emtricitabine/rilpivirine therapy as measured by: - Proportion of subjects with grade 2-4 events - Sum total of all grades of CNS adverse events - Median number of grade 2-4 CNS adverse events Baseline results will be compared with after 12 weeks on tenofovir/emtricitabine/rilpivirine FDC. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy: o Proportion of subjects with grade 2-4 events o Sum total of all grades of CNS adverse events o Median number of grade 2-4 CNS adverse events Baseline results will be compared with 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine FDC. - Change in sleep from baseline compared with after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy as determined by the Pittsburgh Sleep Score - Change in CD4 cell count and % from baseline compared with after 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy - Proportion of subjects maintaining viral suppression to <400 and <50 and <5 copies/ml after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy - Change from baseline in median fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after switching from Atripla to tenofovir/emtricitabine/rilpivirine for 4, 12 and 24 weeks - Proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine compared with baseline and proportion of patients with grade 2-4 non-CNS adverse events after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine compared with baseline - Change from baseline in adherence after 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI) - Change from baseline in quality of life after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine as measured by the EuroQOL questionnaire - Change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12 and week 24 of tenofovir/emtricitabine/r | — |
Countries
United Kingdom
Contacts
Public ContactMark Nelson
Chelsea & Westminster NHS Trust
Outcome results
None listed