Clinical trial NCT03693508: 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: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Severe Immunosuppression
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of patients with undetectable plasma viral load
timeFrame: Week 48
Secondary outcomes:
measure: Proportion of patients with virological failure
timeFrame: From basal until week 48
measure: Proportion of patients with virological failure
timeFrame: From basal visit until week 48
measure: Proportion of patients with virological failure
timeFrame: From basal visit until week 48
measure: Time to virological suppression
timeFrame: From basal until week 48
measure: Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .
timeFrame: From basal until week 48
measure: Time to virological failure
timeFrame: From basal until week 48
measure: Incidence of genotypic resistance in patients with virological failure
timeFrame: From basal until week 48
measure: Changes in viral load
timeFrame: Weeks 4, 8, 12, 24, 36 and 48
measure: Change in the CD4+ lymphocyte count
timeFrame: Week 48
measure: Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL
timeFrame: Week 48
measure: Mean time to reach a CD4 + lymphocyte count> 200 cells / μL
timeFrame: From basal until week 48
Other outcomes:
Locations:
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: H. Clínico San Carlos
city: Madrid
country: Spain
facility: H. Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Sevilla
country: Spain
facility: Hospital virgen del Rocío
Study officials:
References: