PRO 140 for HIV

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 2 & 3 trial • 52 Patients • NCT02483078

Nausea

Fatigue

100%

80%

60%

40%

20%

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

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