NCT04064632

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,609 (actual)
• Sponsor: A.O. Ospedale Papa Giovanni XXIII · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Rilpivirine + darunavir/cobicistat	Switch to a dual ART

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-06-13
• Completion: 2019-11-30
• First posted: 2019-08-22
• Last updated: 2019-08-22

Locations

1 site across 1 country: Italy