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Clinical Trial Summary

Multicenter, randomized, open label pilot clinical trial with two parallel arms aimed to compare the efficacy of Raltegravir (RAL) 1200mg QD vs Darunavir/Cobicistat (DRV-cb) 800-150mg QD both in combination with alafenamide/emtricitabine (TAF/FTC) in patients with Human Inmunodefficiency Virus (HIV) infection and CD4<200 cells/microL


Clinical Trial Description

The trial consists of two parallel arms to study the therapeutic success of 48 weeks, tolerability, immunological recovery, persistence of treatment, safety and results reported by the subject in severely immunocompromised HIV infected patients (with an initial CD4 count <200 cells/μl) naive to antiretroviral therapy.

Included subjects will be randomized two to one (2:1) to RAL 1200mg QD plus FTC/TAF or DRV/cb (800-150mg) plus FTC/TAF. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03842488
Study type Interventional
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact
Status Not yet recruiting
Phase Phase 4
Start date April 2019
Completion date March 2021

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