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Monoclonal Antibodies

PRO 140 SC 350 mg weekly injection (Group A) for HIV/AIDS

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 48 weeks
Awards & highlights

Summary

This trial is testing if a single drug, PRO 140, can keep HIV under control in patients who are stable on their current multi-drug treatment. The drug works by blocking the virus from entering cells. The goal is to see if patients can maintain their health with this simpler treatment.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks 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 who remain on PRO 140 monotherapy regimen at the end of week 48 without experiencing virologic failure
Secondary outcome measures
Central Nervous System (CNS) sub-study: Level of HIV-1 RNA in CSF at T1 (prior to first dose of PRO 140), T4, T16 and VF visits
Central Nervous System (CNS) sub-study: PRO 140 concentration in CSF at T1 (prior to first dose of PRO 140), T4, T16 and VF visits
Central Nervous System (CNS) sub-study: Relationship between PRO 140 concentration in CSF and HIV-1 RNA in CSF
+14 more
Other outcome measures
Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale
Frequency of Treatment-emergent serious adverse events
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions.
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: PRO 140 SC 700 mg weekly injections (Group C)Experimental Treatment1 Intervention
PRO 140 700 mg (175 mg/mL) SC injections per week
Group II: PRO 140 SC 525 mg weekly injections (Group B)Experimental Treatment1 Intervention
PRO 140 525 mg (175 mg/mL) SC injections per week
Group III: PRO 140 SC 350 mg weekly injection (Group A)Experimental Treatment1 Intervention
PRO 140 350 mg (175 mg/mL) SC injections per week

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Who is running the clinical trial?

CytoDyn, Inc.Lead Sponsor
23 Previous Clinical Trials
2,002 Total Patients Enrolled
~61 spots leftby Sep 2025
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