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

NCT03693508 | Completed Phase 4

• 1 other identifier: GESIDA 9216
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

HIV Infections; Severe Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with undetectable plasma viral load

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

  Week 48

Secondary Outcomes (11)

• Proportion of patients with virological failure

  From basal until week 48

• Proportion of patients with virological failure

  From basal visit until week 48

• Proportion of patients with virological failure

  From basal visit until week 48

• Time to virological suppression

  From basal until week 48

• Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .

  From basal until week 48

Study Arms (1)

Arm 1

EXPERIMENTAL

Naive HIV patients with severe immunosuppression.

Drug: Genvoya®

Interventions

Genvoya® DRUG

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

Also known as: TAF/FTC/EVG-cb

Arm 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Hospital Costa del Sol

Marbella, Malaga, Spain

Location

H. Ramón y Cajal

Madrid, 28034, Spain

Location

H. Clínico San Carlos

Madrid, 28040, Spain

Location

H. Doce de Octubre

Madrid, 28041, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, phase 4 study. The naive patients will be treated with elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: April 13, 2018
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)