RPV+DRV/Cobi Dual Therapy in Subjects With HIV Controlled Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- HIV Infection
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients are randomly allocated into two arms: The control arm continues the baseline therapy based on 3 drugs (2 NRTIs) for 24 weeks and then will be switched to receive rilpivirine and cobicistat/darunavir co-formulated tablets (a tablet day). The experimental arm receives rilpivirine and cobicistat/darunavir coformulated tablets at randomization.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04064632
- Collaborators
- San Raffaele University Hospital, Italy
- Investigators
- Not Provided