TMB-365 and TMB-380 in Suppressed HIV-1 Infected Individuals

Phase 1

Active, not recruiting

• Conditions: HIV-1-infection

• Registration Number: NCT05275998
• Lead Sponsor: TaiMed Biologics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-3-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria:Participants must meet all of the following criteria to be included in<br>the study:<br><br> 1. Male or female at least 18 years of age and no greater than 60 years on the day of<br> Screening.<br><br> 2. Asymptomatic HIV-1 infection, documented by any licensed rapid HIV test or HIV<br> enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study<br> entry and confirmed by Geenius™ or a second antibody test by a method other than the<br> initial rapid HIV and/or E/CIA test, or by HIV-1 antigen, plasma HIV-1 RNA viral<br> load at or piror to screening.<br><br> 3. On continuous suppressive cART for 6 months prior to screening with one documented<br> HIV-1 RNA level below the level of detection within 3 months of screening.<br> Continuous cART is defined as no interruptions greater than 3 consecutive days. cART<br> is defined as a DHHS recommended regimen. Study participants should be on a stable<br> regimen, at least 3 months.<br><br> 4. Screening plasma HIV-1 RNA below the limit of detection.<br><br> 5. CD4+ T cell count >350 cells/mm3<br><br> 6. Laboratory values obtained within 30 days prior to the first dose:<br><br> - Hemoglobin > 10.0 g/dL;<br><br> - Platelet count = 100,000/mm3;<br><br> - Absolute neutrophil count = 1,000/mm3;<br><br> - Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5<br> x upper limit of normal (ULN); and<br><br> - Creatinine clearance (CrCl) of = 50 mL/min.<br><br> 7. Willing to comply with the requirements of the protocol and available for follow-up<br> for the planned duration of the study.<br><br> 8. In the opinion of the principal investigator or designee, has understood the<br> information provided; written informed consent needs to be given before any<br> study-related procedures are performed.<br><br> 9. Females of childbearing potential, sexually active with a male sex partner, must<br> agree to use one effective method of contraception from the time of signing the<br> consent to completion of the study, and agree to pregnancy testing as per the<br> Schedule of Events and Procedures. Females of childbearing potential are female<br> participants who are not surgically sterile (no history of bilateral tubal ligation,<br> hysterectomy, or bilateral salpingo-oophorectomy), are not postmenopausal (at least<br> one year without menses), and are not otherwise sterile by medical evaluation.<br><br> - Exclusion Criteria:<br><br>Participants having or meeting any of the following conditions or characteristics will be<br>excluded from the study:<br><br> 1. Suppressed subjects who have not been on a stable DHHS recommended cART regimen for<br> at least 3 months.<br><br> 2. Receipt of any monoclonal antibody for the treatment or prevention of HIV infection<br> except for Sentinel subjects eligible for enrollment into Core groups.<br><br> 3. Suppressed subjects receiving cabotegravir and rilpivirine intramuscularly as<br> maintenance therapy for HIV-1 infection.<br><br> 4. Pregnant, planning a pregnancy during the trial period, or lactating.<br><br> 5. Known allergy/sensitivity or any hypersensitivity to components of the study drug or<br> its formulation, or known allergy to a MAb.<br><br> 6. Major psychiatric illness including any history of schizophrenia or severe<br> psychosis, uncontrolled bipolar disorder requiring acute therapy, or suicide attempt<br> in the previous three years.<br><br> 7. Serious illness requiring systemic treatment and/or hospitalization within 21 days<br> prior to the first dose.<br><br> 8. Receipt of immunomodulatory agents (e.g., interleukins, interferons, cyclosporine,<br> high dose systemic corticosteroids), HIV vaccine, systemic cytotoxic chemotherapy,<br> or investigational therapy within 180 days prior to the first dose.<br><br> 9. Any chronic or acute medical condition, including chronic Hepatits B infection,<br> chronic Hepatitis C infection with viremia, and drug use and alcohol abuse, which in<br> the opinion of the investigator would interfere with evaluation of the study drug.<br><br> 10. Lack of adequate venous access.<br><br> 11. Individuals who have experienced virologic failure during treatment with two or more<br> cART treatment regimens and those being treated with regimens containing either<br> ibalizumab, enfuvirtide, maraviroc, and fostemsavir. Note that a change in treatment<br> regimen for intolerance does not meet criteria for virologic failure.<br><br>

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of TMB-365 and TMB-380 given intravenously every 8 weeks or 12 weeks;Pharmacokinetics of TMB-365 and TMB-380 given intravenously every 8 weeks or 12 weeks;Antiviral activity of the combination of TMB-365 in combination with TMB-380 as maintenance therapy in suppressed HIV infected individuals.