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Monoclonal Antibodies

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 week 25
Awards & highlights

Study Summary

This study is evaluating whether a drug called PRO 140 can improve the health of people with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of the initial 1-week treatment period
Secondary outcome measures
Mean change from Baseline in CD4 cell count at the end of the initial 1-week treatment period
Mean change from Baseline in CD4 cell count at week 25
Mean change from Baseline in HIV-1 RNA levels (log10 copies/mL)
+4 more

Side effects data

From 2018 Phase 2 & 3 trial • 52 Patients • NCT02483078
12%
Diarrhoea
10%
Arthralgia
10%
Injection site haemorrhage
6%
Upper respiratory tract infection
6%
Fatigue
6%
Back pain
6%
Pneumonia
6%
Rash
4%
Headache
4%
Injection site pain
4%
Nausea
4%
Injection site bruising
4%
Abdominal pain
4%
Contusion
4%
Malnutrition
4%
Insomnia
4%
Hypotension
4%
Acute sinusitis
4%
Nasopharyngitis
4%
Urinary tract infection
4%
Laceration
4%
Dehydration
4%
Neck pain
4%
Dizziness
4%
Oedema peripheral
2%
Grand mal convulsion
2%
Lymphadenopathy
2%
Suicidal ideation
2%
Rectal cancer
2%
Schizoaffective disorder
2%
Convulsion
2%
Pancreatitis
2%
Mycobacterium avium complex infection
2%
Septic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2 PRO 140 Open Label for 24 Weeks
Placebo Weekly for 1 Week
Pro 140 Weekly for 1 Week

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
23 Previous Clinical Trials
2,533 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PRO 140 in Treatment-Experienced HIV-1 Subjects
2018. "PRO 140 in Treatment-Experienced HIV-1 Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03902522.
~4 spots leftby Apr 2025
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