At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6 enrolled
Drug / intervention
PRO 140drug
Likely dose
PRO 140 2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects
In Brief
A Phase 3 clinical trial evaluating PRO 140 for HIV-1-infection. Completed, enrolled 6 participants across 17 sites.
Detailed Summary
The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART (antiretroviral therapy) during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesUnited States
CollaboratorsAmarex Clinical Research
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedApr 2019
Primary CompletionMay 2020
TodayJul 2026
First PostedApr 4, 2019
Enrollment StartJun 25, 2018
Primary CompletionMay 18, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.2 years ago
Interventions
PRO 140drug
2 injections of PRO 140 (2 X 2 mL/inj.) Subjects who were previously enrolled and receiving 350 mg dose had the option to move to the 700mg dose for the remainder of the trial.