NCT04064632: PROBE2

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

Status unknown Phase 4 Last updated 22 August 2019

What this trial tests

Phase 4 trial testing Rilpivirine + darunavir/cobicistat in HIV Infection in 1,609 participants. Status unknown.

Timeline

1 February 2017

Primary endpoint
13 June 2019

30 November 2019

Quick facts

Lead sponsor	A.O. Ospedale Papa Giovanni XXIII
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,609
Start date	1 February 2017
Primary completion	13 June 2019
Estimated completion	30 November 2019
Sites	1 location across Italy

Drugs / interventions tested

• Rilpivirine + darunavir/cobicistat — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

A.O. Ospedale Papa Giovanni XXIII — full company profile →

Who can join

18 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Maggiolo F, Gianotti N, Comi L, Di Filippo E, et al · · 2020 · cited 7× · PMID 32129855 · DOI 10.1093/jac/dkaa018
2. 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.
   Maggiolo F, Gianotti N, Comi L, Di Filippo E, et al · · 2021 · PMID 35485333 · DOI 10.1177/13596535211042226