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 (GENIS)

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Severe Immunosuppression
• Intervention / Treatment: Drug: Genvoya®

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: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • H. Ramón y Cajal
  • Madrid, Spain, 28040
    • H. Clínico San Carlos
  • Madrid, Spain, 28041
    • H. Doce de Octubre
  • Madrid, Spain
    • Hospital Infanta Leonor
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío
  • Malaga
    • Marbella, Malaga, Spain
      • Hospital Costa Del Sol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Naive HIV patients with severe immunosuppression.	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.; Other Names: TAF/FTC/EVG-cb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with undetectable plasma viral load	study the effectiveness of the combination of TAF/FTC/EVG-cb	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with virological failure	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.	From basal until week 48
Proportion of patients with virological failure	Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy	From basal visit until week 48
Proportion of patients with virological failure	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.	From basal visit until week 48
Time to virological suppression	viral load <50 copies / mL	From basal until week 48
Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .	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)	From basal until week 48
Time to virological failure	Viral load ≥50 copias/mL	From basal until week 48
Incidence of genotypic resistance in patients with virological failure		From basal until week 48
Changes in viral load	plasma concentration of HIV RNA	Weeks 4, 8, 12, 24, 36 and 48
Change in the CD4+ lymphocyte count		Week 48
Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL		Week 48
Mean time to reach a CD4 + lymphocyte count> 200 cells / μL		From basal until week 48

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: GESIDA 9216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No