A single-arm, open-label, multicenter phase IV trial to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alfa-namide as first-line treatment in naïve patients with HIV-1 infection with severe immunosuppressio

Phase 1

• Conditions: AIDS; MedDRA version: 20.0Level: LLTClassification code 10001509Term: AIDSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-004137-91-ES
• Lead Sponsor: Fundacion SEIMC-GESIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-13
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 <200 cells / µL.
• Patients who are going to be tested for genotypic resistance to inhibitors of intregrasa, emtricitabine or tenofovir (will be scheduled at the screening visit or selection / baseline visit in the event that both visits coincide).
• Creatinine clearance = 30 mL / min before the start of treatment.
• ALT / AST levels not higher than five times normal levels, total bilirubin with normal values, neutrophils> 1000 cells / µL,> 50000 platelets / µL,> 85 g / L Hb, and serum amylase levels <1.5 times the upper normal limit before the start of treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified