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Monoclonal Antibodies
PRO 140 in Treatment-Experienced HIV-1 Subjects
Phase 2 & 3
Waitlist Available
Research Sponsored by CytoDyn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests PRO 140, a medication that helps block HIV from entering immune cells, in patients whose HIV is not controlled by current treatments. The study focuses on adults with a specific type of HIV who have resistance to multiple HIV drugs. The goal is to see if PRO 140, combined with other treatments, can better control the virus and is safe to use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2018 Phase 2 & 3 trial • 52 Patients • NCT024830784%
Nausea
4%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pro 140 Weekly for 1 Week
Placebo Weekly for 1 Week
Part 2 PRO 140 Open Label for 24 Weeks
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Leronlimab (PRO 140)Experimental Treatment1 Intervention
Subjects will be on existing ART for one week followed by PRO 140 700mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRO 140
2004
Completed Phase 3
~150
Find a Location
Who is running the clinical trial?
CytoDyn, Inc.Lead Sponsor
24 Previous Clinical Trials
2,593 Total Patients Enrolled