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Monoclonal Antibodies

TMB-365 + TMB-380 for HIV

Phase 1 & 2
Recruiting
Led By Jay Lalezari, MD
Research Sponsored by TaiMed Biologics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female at least 18 years of age and no greater than 60 years on the day of Screening.
Females of childbearing potential, sexually active with a male sex partner, must agree to use one effective method of contraception from the time of signing the consent to completion of the study, and agree to pregnancy testing as per the Schedule of Events and Procedures. Females of childbearing potential are female participants who are not surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), are not postmenopausal (at least one year without menses), and are not otherwise sterile by medical evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Study Summary

This trial is testing a combination of two antibodies, TMB-365 and TMB-380, for safety and how well they work in people with HIV who are already taking other medication.

Who is the study for?
Adults aged 18-60 with asymptomatic HIV-1, on stable cART for at least 6 months without interruption, and have undetectable viral loads. They must have a CD4+ T cell count over 350 cells/mm3 and meet certain lab value criteria. Women of childbearing potential must agree to use contraception and undergo pregnancy tests.Check my eligibility
What is being tested?
The trial is testing the safety and how the body processes different doses of two monoclonal antibodies, TMB-365 and TMB-380 (VRC-07-523LS), in individuals with suppressed HIV who are on cART. The goal is to find optimal dosing for these drugs as maintenance therapy without oral cART for 24 weeks.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to sensitivity to components in the study drugs or other monoclonal antibodies, infusion-related reactions, immune system changes, or exacerbation of underlying conditions like allergies or asthma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I agree to use birth control and undergo pregnancy tests if I can still have children.
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I have HIV but do not show symptoms, confirmed by tests.
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I agree to use birth control and undergo pregnancy tests if I can still have children.
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I have been on consistent HIV treatment for 6 months with an undetectable viral load in the last 3 months.
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I have HIV but do not show symptoms, confirmed by tests.
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I am between 18 and 60 years old.
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I am between 18 and 60 years old.
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I have HIV but do not show symptoms, confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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
Antiviral activity of the combination of TMB-365 in combination with TMB-380 as maintenance therapy in suppressed HIV infected individuals.
Pharmacokinetics of TMB-365 and TMB-380 given intravenously every 8 weeks or 12 weeks
Safety of TMB-365 and TMB-380 given intravenously every 8 weeks or 12 weeks
Other outcome measures
Immunogenicity of TMB-365 and TMB-380 infusions
Resistance to TMB-365 and TMB-380

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sentinel Group 3Experimental Treatment1 Intervention
10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
Group II: Sentinel Group 2Experimental Treatment1 Intervention
10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
Group III: Sentinel Group 1Experimental Treatment1 Intervention
10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.
Group IV: Core Group 1Experimental Treatment1 Intervention
20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 52.

Find a Location

Who is running the clinical trial?

TaiMed Biologics Inc.Lead Sponsor
8 Previous Clinical Trials
341 Total Patients Enrolled
Jay Lalezari, MDPrincipal InvestigatorQuest Clinical Research
1 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

TMB-365/TMB-380 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05275998 — Phase 1 & 2
HIV Research Study Groups: Core Group 1, Sentinel Group 1, Sentinel Group 2, Sentinel Group 3
HIV Clinical Trial 2023: TMB-365/TMB-380 Highlights & Side Effects. Trial Name: NCT05275998 — Phase 1 & 2
TMB-365/TMB-380 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05275998 — Phase 1 & 2

Frequently Asked Questions

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

What is the participant count for this research project?

"The total number of participants necessary to pursue the trial is 90, which TaiMed Biologics Inc. will be sourcing from Quest Clinical Research (San Francisco) and Gary Richmond MD PA (Fort Lauderdale)."

Answered by AI

Is this research endeavor presently recruiting participants?

"Affirmative. According to the details hosted on clinicaltrials.gov, this trial is actively recruitting participants since its launch date of July 5th 2022 and presently enrolling 90 patients from 6 different locations. The data was last updated on October 25th 2022."

Answered by AI

What is the prevalence of this medical experiment in city?

"The current roster of participating medical centres consists of Quest Clinical Research in San Francisco, Gary Richmond MD PA in Fort Lauderdale, and Crofoot Research Center Inc. in Houston, alongside 6 other locations."

Answered by AI

Could individuals younger than 55 years old meet the requirements of this experiment?

"This trial has set the age limit for applicants to be between 18 and 60 years old. Any patients below 18 or above 65 can join one of the other 94 clinical trials that are relevant to their situation."

Answered by AI

What qualifications must participants meet in order to partake in this trial?

"The criteria for joining this medical study necessitates that participants possess HIV-1, stand between 18 and 60 years of age, with the total number of recruiters expected to be approximately 90."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Quest Clinical Research
Gary Richmond, MD, PA
Orlando Immunology Center
Other
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. Crofoot Research Center, Inc.: < 24 hours
~4 spots leftby Apr 2024