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Virus Therapy

PRO 140 350 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 200 weeks
Awards & highlights

Study Summary

This trial is designed to see if a drug can keep people with HIV suppressed long term with no other drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~200 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 200 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
Long term clinical safety of PRO 140 350mg, 525, or 700 mg monotherapy regimen will be measured based on participants With Treatment-Related Adverse Events
Proportion of participants experiencing virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured
Secondary outcome measures
Mean change in CD4 cell count, at each visit within the Treatment Phase for all subjects will and within each treatment group will be measured
Proportion of participants achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured
Proportion of virologic failure subjects achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) with re-initiation of previous baseline antiretroviral regimen for all subjects and within each treatment group will be measured
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: PRO 140 700 mgExperimental Treatment1 Intervention
PRO 140 700mg weekly SQ injection.
Group II: PRO 140 525 mgExperimental Treatment1 Intervention
PRO 140 525mg weekly SQ injection.
Group III: PRO 140 350 mgExperimental Treatment1 Intervention
PRO 140 350mg weekly SQ injection.

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Who is running the clinical trial?

CytoDyn, Inc.Lead Sponsor
23 Previous Clinical Trials
2,502 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still recruiting patients for this clinical trial?

"The most up-to-date information on clinicaltrials.gov suggests that this study is not actively recruiting patients. This trial was originally posted on August 29th, 2017 and the last update was made on March 4th, 2022. There are a total of 110 other trials seeking patients at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study
2017. "An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05271370.
~7 spots leftby Apr 2025
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