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RPV+DRV/Cobi Dual Therapy in Subjects With HIV Controlled Infection — PROBE2  

HIV Infection Clinical Trial

Official title:
Multicenter, National, Prospective, Open Label, Randomized, Pilot, Proof-of-concept Study on the Use of Rilpivirine Plus Darunavir/Cobicistat as Substitutive Agents in Virologic Suppressed Patients

Clinical Trial Summary

This study evaluates efficacy and safety of rilpivirine as substitutive agent for the nucleosidic backbone of HAART in virologic suppressed patients when combined with cobicistat-boosted darunavir.

Clinical Trial Description

HAART is generally based on the combination of three active drugs. Two of them, usually defined the backbone, belong to the nucleosidic analogues class (NRTI). In the last years, drugs of this class have been associated to several long-term adverse events of HAART such as lipoatrophy, cardiovascular diseases, bone and kidney toxicity. Furthermore the need of a triple drug regimen has recently been questioned as maintenance therapy in well controlled chronically treated subjects. In this setting, less drug regimens (LDR) have been proposed. LDR would allow a reduced exposure to drugs and eventually limit drug-drug interactions, drug-related toxicities and would allow treatment simplification so to enhance HAART acceptability, tolerability and persistence. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04064632
Study type Interventional
Source A.O. Ospedale Papa Giovanni XXIII
Contact
Status Active, not recruiting
Phase Phase 4
Start date February 1, 2017
Completion date November 30, 2019
View Details
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