drugset / Trial / NCT04064632
RPV+DRV/Cobi Dual Therapy in Subjects With HIV Controlled Infection
Phase 4
Unknown
1609 enrolled
A.O. Ospedale Papa Giovanni XXIII
San Raffaele University Hospital, Italy · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-02-01
- Primary completion
- 2019-06-13
- Completion
- 2019-11-30
Publications
- Maggiolo F, Gianotti N, Comi L, Di Filippo E, Fumagalli L, Nozza S, Galli L, Valenti D, Rizzi M, Castagna A. Rilpivirine plus cobicistat-boosted darunavir as alternative to standard three-drug therapy in HIV-infected, virologically suppressed subjects: Final results of the PROBE 2 trial. Antivir Ther. 2021 May;26(3-5):51-57. doi: 10.1177/13596535211042226. Epub 2021 Oct 27.
- Maggiolo F, Gianotti N, Comi L, Di Filippo E, Fumagalli L, Nozza S, Galli L, Valenti D, Rizzi M, Castagna A. Rilpivirine plus cobicistat-boosted darunavir as a two-drug switch regimen in HIV-infected, virologically suppressed subjects on steady standard three-drug therapy: a randomized, controlled, non-inferiority trial (PROBE 2). J Antimicrob Chemother. 2020 May 1;75(5):1332-1337. doi: 10.1093/jac/dkaa018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 800 mg | Oral |
| Subject | Rilpivirine | Small molecule | 25 mg | Oral |
| Background | Cobicistat | Small molecule | 150 mg | Oral |