AIDS MedDRA version: 20.0 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Genvoya
Pharmaceutical Form: Tablet
INN or Proposed INN: EMTRICITABINE
CAS Number: 143491-57-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN
Sponsors
Fundacion SEIMC-GESIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have voluntarily granted informed consent before carrying out the specific procedures of the trial. • Adult patients (age =18 years) of both sexes. • Patients with HIV-1 infection with severe immunosuppression, defined by a concentration of CD4 + lymphocytes 1000 cells / µL,> 50000 platelets / µL,> 85 g / L Hb, and serum amylase levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient receiving any concomitant treatment described as not allowed. Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical file. • Patient receiving therapies with interferon, interleukin 2, cytotoxic chemotherapy or immunosuppressants at the baseline visit. • Patients with neoplasms, with the exception of skin carcinoma (excluding melanoma and hawthorn) and anal cancer in situ (stage 0). • Patient with any medical or psychological, sociological or geographical alteration, toxic habit (drugs, alcohol) that, in the opinion of the investigator, could interfere in the compliance of the study by the patient. These conditions will be discussed with the patient before their inclusion in the trial. • Patients with any medical or psychological alteration that, in the opinion of the researcher, could compromise the patient's ability to understand and complement the questionnaires and scales used in the study. • Patient in treatment with any investigational drug / product or who is participating in a clinical trial using an investigational product, with the exception of studies in which the study treatment was completed more than 12 weeks ago. • Pregnant women, in breastfeeding period or with a positive pregnancy test in the selection period; women of childbearing age and sexually active who are not willing to use an adequate contraceptive method (such as oral contraceptives, intrauterine device or contraceptive barrier method together with spermicide or surgical sterilization) during the study and up to 3 months after the administration of the last dose of the study treatment. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months. • Patients with severe hepatic impairment (Child-Pugh Class C). Sugerir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the therapeutic success based on the percentage of patients with an undetectable plasma viral load (HIV-1 RNA level <50 copies / mL) at 48 weeks, without therapeutic failure, according to the FDA Snapshot algorithm;Secondary Objective: • Evaluate the proportion of virological failures. • Evaluate the proportion of ART interruptions due to causes other than virological failure (non-virological failure). • Evaluate the time to virological suppression. • To evaluate the proportion of patients with virological failure, having previously been suppressed. • Evaluate the time to virological failure. • To evaluate the incidence of genotypic resistance in patients with virological failure. • Evaluate changes in viral load from the beginning of treatment. • Evaluate immune recovery based on changes in the CD4 + lymphocyte count. • Evaluate the safety profile of E / C / F / TAF under clinical practice conditions. • Evaluate the patient's satisfaction with the treatment. • Evaluate adherence to treatment during the study;Primary end point(s): Proportion of patients with plasma viral load of HIV-1 RNA <50 copies / mL at 48 weeks, without therapeutic failure, according to the FDA Snapshot algorithm (Annex 3) in the population "intention to treat modified" .;Timepoint(s) of evaluation of this end point: - Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 4, 8, 12, 24, 36 and 48;Secondary end point(s): - Proportion of patients with virological failure, including patients with plasma HIV-1 RNA load =50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely by lack / loss of efficacy in which the last viral load was =50 copies / mL or in which antiretroviral treatment is modified before 48 weeks. - Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy. - Proportion of patients who interrupt treatment prematurely for other reasons (other than an adverse event, death or loss of efficacy) and whose last viral load at the time of quitting was =50 copies / mL. - Proportion of patients in whom antiretroviral treatment is modified before the end of the study. - Proportion of patients who interrupt treatment prematurely for safety reasons, including adverse events and diseases associated with AIDS - Proportion of patients who interrupt treatment prematurely for other reasons (withdrawal of informed consent, loss of follow-up, etc.) and whose last viral load at the time of abandonment was =50 copies / mL. - Proportion of patients with absence / loss of virological data in the window of week 48 that continue in the study at 48 weeks. - Time to virological suppression (viral load 1000 copies / mL at week 24 or 2 consecutive viral loads> 50 copies / mL (at least 2 weeks apart) while receiving ART, having previously been suppressed - Time to virological failure (viral load =50 copies / mL). - Incidence of genotypic resistances in patients with virological failure, and description of them. - Changes in viral load (plasma concentration of HIV RNA) from the start of treatment to weeks 4, 8, 12, 24, 36, and 48. - Change in the count of CD4 + lymphocytes from the start of treatment until week 48. - Proportion of patients who have a CD4 + count> 200 | — |
Countries
Spain
Contacts
Public ContactMaria Yllescas
Fundación SEIMC-GESIDA
Outcome results
None listed