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Keeping HIV suppressed with two IV antibodies (TMB-365 and TMB-380)

A Phase 2b Study of the Safety, Pharmacokinetics, and Efficacy of the Combination of TMB-365 and TMB-380 as Maintenance Therapy in HIV-1 Infected Individuals Suppressed With Combination Antiretroviral Therapy

Phase 2 Interventional TaiMed Biologics Inc. · NCT07215468

This test checks whether two IV antibodies (TMB-365 and TMB-380) given every 8 weeks can keep people with well-controlled HIV safely off daily oral antiretroviral therapy for 48 weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment75 (estimated)
Ages18 Years and up
SexAll
SponsorTaiMed Biologics Inc. Industry-sponsored
Drugs / interventionsibalizumab, cART, chemotherapy
Locations10 sites (San Francisco, California and 9 other locations)
Trial IDNCT07215468 on ClinicalTrials.gov

What this trial studies

This phase 2 trial randomizes adults with HIV who are virally suppressed on stable oral cART to receive either intravenous infusions of TMB-365 plus TMB-380 every eight weeks or to continue their daily oral antiretroviral regimen for 48 weeks. TMB-365 binds the CD4 receptor and TMB-380 (VRC07-523LS) is a broadly neutralizing antibody that targets HIV, and together they aim to block viral entry. Participants assigned to the antibody arm discontinue oral cART and attend scheduled clinic visits for safety monitoring and plasma HIV-1 RNA testing to detect loss of suppression. The primary comparison is maintenance of plasma HIV-1 RNA <50 copies/mL between the antibody combination and continued oral cART over 48 weeks.

Who should consider this trial

Good fit: Adults with asymptomatic HIV who have been on continuous suppressive cART for at least six months with a screening viral load <50 copies/mL and CD4 count >350 cells/mm3 are the intended candidates.

Not a fit: People with recent detectable viremia, CD4 counts ≤350 cells/mm3, or relevant lab abnormalities (for example hemoglobin <10 g/dL) are unlikely to benefit or qualify for this protocol.

Why it matters

Potential benefit: If successful, this approach could allow some people with suppressed HIV to maintain viral control without daily oral therapy.

How similar studies have performed: Previous studies of single and combination broadly neutralizing antibodies have shown they can delay viral rebound in some participants, but replacing daily ART remains experimental.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. At least 18 years of age on the day of Screening.
2. Asymptomatic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by Geenius™ or a second antibody test by a method other than the initial rapid HIV and/or E/CIA test, or by HIV-1 antigen, plasma HIV-1 RNA viral load at or prior to screening.
3. On continuous suppressive cART for at least 6 months prior to Screening with one documented HIV-1 RNA level \<50 copies/mL within 6 months of Screening. Continuous cART is defined as no interruptions greater than 3 consecutive days. cART is defined as a DHHS recommended regimen. Study participants should be on a stable oral regimen for at least 3 months prior to Screening.
4. Screening plasma HIV-1 RNA \< 50 copies/mL
5. CD4+ T cell count \>350 cells/mm3
6. Laboratory values obtained within 35 days prior to the first dose:

   * Hemoglobin ≥ 10.0 g/dL
   * Platelet count ≥ 100,000/mm3
   * Absolute neutrophil count ≥ 1,000/mm3
   * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 x upper limit of normal (ULN)
   * Creatinine clearance (CrCl) of ≥ 50 mL/min
7. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
8. 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.
9. Persons of childbearing potential sexually active with a partner who can impregnate them, 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. Persons of childbearing potential are participants born female 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.

Exclusion Criteria:

1. Receipt of any monoclonal antibody for the treatment or prevention of HIV infection.
2. Receiving cabotegravir and rilpivirine intramuscularly as maintenance therapy for HIV-1 infection.
3. Pregnant, planning a pregnancy during the trial period, or lactating.
4. Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation, or known allergy to a MAb.
5. History of severe allergic reactions to medications, vaccinations, or monoclonal antibody therapy for other conditions such as COVID.
6. Major psychiatric illness including any history of schizophrenia or severe psychosis, uncontrolled bipolar disorder requiring acute therapy, or suicide attempt in the previous three years.
7. Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to Baseline.
8. Receipt of immunomodulatory agents (e.g., interleukins, interferons, cyclosporine, high dose systemic corticosteroids), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 180 days prior to Baseline.
9. Any chronic or acute medical condition, including chronic Hepatitis B infection, chronic Hepatitis C infection with viremia, drug use and alcohol abuse, which in the opinion of the investigator would interfere with evaluation of the study drug.
10. Lack of adequate venous access.
11. Individuals who have experienced virologic failure during treatment with two or more cART treatment regimens and those being treated with regimens containing either ibalizumab, enfuvirtide, maraviroc, or fostemsavir. Note that a change in treatment regimen for intolerance does not meet criteria for treatment failure.

Where this trial is running

San Francisco, California and 9 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV -1 InfectionHIV-1 maintenance treatmentHIV switch therapyBroadly neutralizing antibodyHIV post-attachment inhibitormonoclonal antibody
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.