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PRO 140 350mg weekly SQ injection. for HIV/AIDS
Phase 2
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
Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure.
Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 160 weeks
Awards & highlights
Study Summary
This trial will study the long-term effects of PRO 140, a drug used to treat HIV. The trial will last 161 weeks and will look at the safety and efficacy of the drug.
Eligible Conditions
- HIV/AIDS
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 160 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~160 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to virologic failure after initiating PRO 140 monotherapy.
Secondary outcome measures
Change in Quality of Life metrics (up to TE107)
Mean change in CD4 cell count
Mean change in viral load (HIV-1 RNA levels)
+1 moreOther 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 study participants(using Visual Analogue Scale) and by investigator-evaluation of injection site reactions.
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: PRO 140Experimental 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
2,530 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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