A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

April 13, 2018

Estimated Primary Completion Date

May 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of patients with undetectable plasma viral load[ Time Frame: Week 48 ]

study the effectiveness of the combination of TAF/FTC/EVG-cb

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Proportion of patients with virological failure[ Time Frame: From basal until week 48 ]
Proportion of patients with Plasma viral load of HIV-1 RNA ≥50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely due to lack / loss of efficacy in which the last viral load was ≥50 copies / mL or in which the antiretroviral treatment was modified before 48 weeks.
Proportion of patients with virological failure[ Time Frame: From basal visit until week 48 ]
Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy
Proportion of patients with virological failure[ Time Frame: From basal visit until week 48 ]
Proportion of patients who interrupt the treatment prematurely by others reasons (other than an adverse event, death or loss of effectiveness) and whose last viral load at the time of abandonment was ≥50 copies / mL.
Time to virological suppression[ Time Frame: From basal until week 48 ]
viral load <50 copies / mL
Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .[ Time Frame: From basal until week 48 ]
virological failure defined by protocol as viral load> 1000 copies / mL at week 24 or 2 consecutive viral loads> 50 copies / mL (at least 2 weeks apart)
Time to virological failure[ Time Frame: From basal until week 48 ]
Viral load ≥50 copias/mL
Incidence of genotypic resistance in patients with virological failure[ Time Frame: From basal until week 48 ]
Changes in viral load[ Time Frame: Weeks 4, 8, 12, 24, 36 and 48 ]
plasma concentration of HIV RNA
Change in the CD4+ lymphocyte count[ Time Frame: Week 48 ]
Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL[ Time Frame: Week 48 ]
Mean time to reach a CD4 + lymphocyte count> 200 cells / μL[ Time Frame: From basal until week 48 ]

Descriptive Information

Brief Title ^ICMJE

A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression

Official Title ^ICMJE

Phase IV, Open, Multicentre, Single-arm Study to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression.

Brief Summary

Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.

Detailed Description

The patients included in the study will be treated during 48 weeks and will have to perform the selection/basal visit, week 4 visit, week 8 visit, week 12 visit, week 24 visit, week 48 visit and follow up visit.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, phase 4 study. The naive patients will be treated with elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Genvoya®
Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.

Study Arms

Experimental: Arm 1
Naive HIV patients with severe immunosuppression.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 31, 2020

Estimated Primary Completion Date

May 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Patients able to give their written consent to participate in the study after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment - Adult patients (age ≥18 years) of both sexes - Patients with HIV-1 infection with severe immunosuppression, defined by a concentration of CD4 + lymphocytes <200 cells / μL - Patients who are allowed to perform a genotypic resistance test to inhibitors of intregrase, emtricitabine or tenofovir - Creatinine clearance ≥ 30 ml / min before the start of treatment - Alanine transaminase (ALT) / Aspartate transaminase (AST) levels not higher than five times normal levels, total bilirubin with normal values, neutrophils> 1000 cells / μL,> 50000 platelets / μL,> Hb level of 85 g / L and serum amylase levels <1 , 5 times higher normal limit before the start of treatment Exclusion Criteria: - Patient who undergoes a concomitant treatment not allowed. Patient with documented intolerance or hypersensitivity to the study medication, or who is contraindicated to use it, attending a technical file - Patient receiving therapies with interferon, interleukin 2, cytotoxic chemotherapy or immunosuppressants at the baseline visit. - Patients with neoplasms, an exception of skin cancer and anus cancer in situ (stage 0) - Patient with any medical or psychological, sociological or geographical alteration, toxic habit (drugs, alcohol) that, a criterion of the researcher, may interfere in the fulfillment 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, a criterion of the investigator, an involuntary factor of the patient's ability to understand and complement the questionnaires and scales used in the study - Patient in a treatment with any type of drug / product under investigation or who is participating in a clinical trial that uses a product under investigation, 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 during the study and up to 3 months after the administration of the last dose of study treatment. Some women in adulthood have undergone permanent infertility procedures or amenorrheic procedures for less than 12 months - Patients with severe hepatic impairment (Child-Pugh Class C).

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Fundacion SEIMC-GESIDA

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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