A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects
Phase of Trial: Phase II/III
Latest Information Update: 13 Oct 2017
At a glance
- Drugs PRO 140 (Primary) ; Antiretrovirals
- Indications HIV infections
- Focus Registrational; Therapeutic Use
- Sponsors CytoDyn
- 13 Oct 2017 Planned number of patients changed from 30 to 50, according to a CytoDyn Inc. media release.
- 13 Oct 2017 According to a CytoDyn Inc. media release, The FDA accepted the 40 patients currently enrolled as evaluable and further agreed that the Data Monitoring Committee can conduct an interim efficacy analysis of primary endpoint. The FDA also confirmed that 50 patients will be required for the completion of this trial and agreed to allow more flexibility in the enrollment criteria for the remaining 10 patients.
- 05 Sep 2017 Planned End Date changed from 1 Aug 2019 to 1 Apr 2018.