TMB-365 + TMB-380 for HIV

Recruiting at 7 trial locations

Overseen By Edwin DeJesus, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: TaiMed Biologics Inc.

Must be taking: cART

Must not be taking: Cabotegravir, Rilpivirine

Disqualifiers: Pregnancy, Schizophrenia, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests two special proteins, TMB-365 and TMB-380, in people with HIV who are already managing their condition with regular medication. The proteins work by blocking the virus from entering cells and attaching directly to it. The goal is to see if these proteins can maintain control of HIV without regular medication.

Will I have to stop taking my current medications?

Participants will need to stop their current oral cART (combination antiretroviral therapy) for 24 weeks as part of the trial.

What data supports the effectiveness of the drug TMB-365/TMB-380 for HIV?

The research highlights the importance of potency, immune improvement, and durability in HIV treatments, which are key factors that patients prioritize. Although specific data on TMB-365/TMB-380 is not provided, these attributes are crucial for effective HIV management, suggesting that if TMB-365/TMB-380 possesses these qualities, it could be effective. ^{1 2 3 4 5}

Research Team

Jay Lalezari, MD

Principal Investigator

Quest Clinical Research

Eligibility Criteria

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.

Inclusion Criteria

Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study

I agree to use birth control and undergo pregnancy tests if I can still have children.

In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed.

Exclusion Criteria

I have not received monoclonal antibodies for HIV except as a Sentinel subject.

Any chronic or acute medical condition, including chronic Hepatits B infection, chronic Hepatitis C infection with viremia, and drug use and alcohol abuse, which in the opinion of the investigator would interfere with evaluation of the study drug

I haven't taken immune system drugs, HIV vaccines, chemotherapy, or experimental treatments in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sentinel Group Treatment

Participants receive a single IV dose of TMB-365 and TMB-380 while continuing cART, followed by safety and pharmacokinetics assessment

12 weeks

Multiple visits for infusion and monitoring

Core Group Treatment

Participants receive multiple IV doses of TMB-365 and TMB-380 as a stand-alone maintenance regimen for 24 weeks

24 weeks

Infusions every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up visits post-treatment

Treatment Details

Interventions

• TMB-365/TMB-380

Trial Overview 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.

Participant Groups

Group I: Sentinel Group 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

TaiMed Biologics Inc.

Lead Sponsor

Trials

9

Recruited

390+

Findings from Research

In a study of 307 antiretroviral-experienced HIV-1-infected individuals, the 1-year probability of virological failure on an ABC + TDF regimen was 34%, with higher failure rates linked to the absence of a potent cART regimen and a greater number of prior treatments.

For patients starting therapy with a viral load ≤400 copies/ml, the virological failure rate was lower at 17%, indicating that initial viral load and treatment history significantly influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of antiretroviral regimens containing abacavir with tenofovir in treatment-experienced patients: predictors of virological response and drug resistance evolution in a multi-cohort study. Di Giambenedetto, S., Torti, C., Prosperi, M., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of antiretroviral regimens containing abacavir with tenofovir in treatment-experienced patients: predictors of virological response and drug resistance evolution in a multi-cohort study. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Viro-Immunological, Clinical Outcomes and Costs of Switching to BIC/TAF/FTC in a Cohort of People Living with HIV: A 48-Week Prospective Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The importance of potency and durability in HIV patient antiretroviral therapy preferences: a telephone survey. [2005]

4. England pubmed.ncbi.nlm.nih.gov

Triple nucleoside combination zidovudine/lamivudine/abacavir versus zidovudine/lamivudine/nelfinavir as first-line therapy in HIV-1-infected adults: a randomized trial. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy. [2021]