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Monoclonal Antibodies

ibalizumab-uiyk for HIV

Phase 3

Waitlist Available

Research Sponsored by TaiMed Biologics 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 day 1 infusion versus day 85 iv push

Awards & highlights

Study Summary

This trial is designed to see if it's safe to give 800mg of the drug Trogarzo via IV push or intramuscular injection, and to measure how well it is tolerated and how it moves through the body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 infusion versus day 85 iv push

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 infusion versus day 85 iv push

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 infusion versus day 85 iv push for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetics(1) of Trogarzo infusion versus IV Push in Core Group

Pharmacokinetics(1) of Trogarzo infusion versus IV Push in Sentinel Group

Pharmacokinetics(1) of Trogarzo infusion versus intramuscular injection in the Intramuscular Injection Group

+6 more

Secondary outcome measures

Percent of HIV-infected subjects in the Core Group who fail to maintain virologic control

Percent of HIV-infected subjects in the Intramuscular Injection Group who fail to maintain virologic control

Percent of subjects in the Sentinel Group who fail to maintain virologic control

Trial Design

3Treatment groups

Experimental Treatment

Group I: Sentinel GroupExperimental Treatment1 Intervention

Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.

Group II: Intramuscular Injection GroupExperimental Treatment1 Intervention

HIV-infected Intramuscular Injection Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via Intramuscular Injection. Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.

Group III: Core GroupExperimental Treatment1 Intervention

HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ibalizumab-uiyk

2019

Completed Phase 3

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TaiMed Biologics Inc.Lead Sponsor

8 Previous Clinical Trials

385 Total Patients Enrolled

WestatOTHER

43 Previous Clinical Trials

37,128 Total Patients Enrolled

Martin Markowitz, MDStudy ChairTaiMed Biologics Inc. - Consultant

9 Previous Clinical Trials

920 Total Patients Enrolled

Frequently Asked Questions

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

What is the precedent for ibalizumab-uiyk's medical efficacy?

"1 ibalizumab-uiyk clinical trial is currently underway and in Phase 3. The study locations are primarily situated in Los Angeles, California, though there are 4 total centres running trials."

Answered by AI

What is the mortality rate for ibalizumab-uiyk patients?

"Ibalizumab-uiyk is in Phase 3 clinical trials, meaning that while there is evidence of efficacy, multiple rounds of testing have confirmed its safety."

Answered by AI

In how many different geographic locations is this study being conducted?

"Currently, there are 4 centres conducting this study: North Texas Infectious disease Consultants in Dallas, Gary Richmond MD, PA in Fort Lauderdale, Orlando Immunology Center in Orlando, and 4 additional locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection

2019. "Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913195.