HIV
Conditions
Interventions
Trade Name: Eviplera
Product Name: Eviplera
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Emtricitabine
CAS Number: 14349
Sponsors
St Stephen's AIDS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is male or female aged 18 years or above 2. Has HIV-1 infection documented in their medical notes 3. Has signed the Informed Consent Form voluntarily 4. Is willing to comply with the protocol requirements 5. Has been on Atripla for at least 12 weeks before enrolment 6. Has an undetectable HIV-plasma viral load at screening by local assay (single re-test allowed) 7. Has a CD4 cell count at screening >50 cells/mm3 8. Has an estimated glomerular filtration rate (MDRD) >50 ml/min. 9. Has no significant CNS symptoms which may be attributable to EFV. 10. If female and of childbearing potential, is using effective birth control methods (for example, hormonal contraceptive, condom, abstinence, IUD, 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 11. 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) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Patients meeting 1 or more of the following criteria cannot be selected: 1. Infected with HIV-2 2. Using any concomitant therapy disallowed as per SPC for the study drugs (e.g proton pump inhibitors ) 3. Has acute viral hepatitis including, but not limited to, A, B, or C 4. Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Patients 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. 5. Any investigational drug within 30 days prior to the trial drug administration 6. Has ever received rilpivirine in the past 7. Any clinical evidence of baseline resistance mutations, prior to commencing antiretroviral therapy. 8. Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption 9. Severe hepatic impairment (defined as Child-Pugh-Turcotte (CPT) Score C). 10. If female, she is pregnant or breastfeeding 11. 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). 12. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial. 13. If participating in the MR Imaging substudy, any contraindications to magnetic resonance scanning according to local radiology guidelines (to be assessed by MR Spectroscopy Imaging Department)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess changes in neuropsychiatric and central nervous system (CNS) parameters in patients without perceived Central Nervous System (CNS) symptoms after 4 weeks of switching from Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV).; Secondary Objective: • To assess changes in neuropsychiatric and central nervous system (CNS) parameters after 12 and 24 weeks of switching from Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV). • To assess the proportion of patients with undetectable viral load (by local assay) at weeks 4, 12 and 24 post switch. • To assess the proportion of patients with viral load below 400 copies/mL at weeks 4, 12 and 24 post switch. • To assess the change in CD4+ count at week 12 and 24 post switch. • To assess the proportion of patients with grade 2-4 laboratory adverse events (excluding lipids) and the proportion with grade 2-4 non-CNS adverse events after 4, 12 and 24 weeks of switching from Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV). • To assess the change in mean fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides at week 4, 12 and 24 post switch. • To assess the change in quality of life at week 4, 12 and 24 post switch. • To assess change in neurocognitive function at wee ; Primary end point(s): Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline as measured by: o The proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity (as defined by the ACTG adverse event scale and collected by CNS questionnaire. o The median number of grade 2-4 neuropsychiatric and CNS toxicity (as defined by the ACTG adverse event scale and collected by CNS questionnaire o The median CNS score (derived from t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline as measured by: o The proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity (any and for each individual toxicity) (as defined by the ACTG adverse event scale and collected by CNS questionnaire). o The median number of grade 2-4 neuropsychiatric and CNS toxicity (as defined by the ACTG adverse event scale and collected by CNS questionnaire). o The median CNS score (derived from the sum of toxicity of all grades collected in the CNS questionnaire). o Change in sleep score using the Pittsburgh Sleep Questionnaire. • Change in neuropsychiatric and CNS parameters as measured by the change in the Hospital Anxiety and Depression Scale (HADS) at 4, 12 and 24 weeks as compared with baseline. • Proportion of patients with undetectable viral load (by local assay) at weeks 4, 12 and 24. • Proportion of patients with viral load below 400 copies/mL at weeks 4, 12 and 24. • Change in CD4+ count at week 12 and 24 compared to baseline. • Proportion of patients with grade 2-4 laboratory adverse events (excluding lipids) and proportion of patients with grade 2-4 non-CNS adverse events at 4, 12 and 24 weeks compared with baseline. • Change in mean fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after 4, 12 and 24 weeks compared with baseline. • Change in quality of life (as assessed by EQ-5D questionnaire) at 4, 12 and 24 weeks compared with baseline. • Change in neurocognitive function as determined by computerised neurocognitive assessment and Instrumental Activities of Daily Life (IADL) questionnaire (no computerised cognitive testing at week 12) at 4, 12 and | — |
Countries
United Kingdom
Contacts
Public ContactJustine Boles
St Stephen's AIDS Trust
Outcome results
None listed