HIV -1 InfectionPhase 2VISTANCT07215468
HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study
A Phase 2 study testing TMB-365, TMB-380 and Baseline ART in people with HIV -1 Infection, run by TaiMed Biologics Inc. at 10 sites in United States.
Trial summary
TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV -1 Infection
- What is being tested?
- TMB-365, TMB-380 and Baseline ART
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Dec 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age on the day of Screening.
- 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.
- 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.
- Screening plasma HIV-1 RNA < 50 copies/mL
- CD4+ T cell count >350 cells/mm3
- Laboratory values obtained within 35 days prior to the first dose:
Show all 14Show fewer
- 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
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- 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.
- 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.
Who cannot join
- History of receipt of any monoclonal antibody for any treatment, including bNAbs, whether naturally occurring, such as VRC01, or modified, such as VRC07-523LS.
- History of receipt of any long-acting ARV for treatment or prevention of HIV (investigational and commercial), including but not limited to cabotegravir/rilpivirine combination, lenacapavir, and islatravir.
- Pregnant, planning a pregnancy during the trial period, or lactating.
- Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation, or known allergy to a MAb.
- History of severe allergic reactions to medications, vaccinations, or monoclonal antibody therapy for other conditions such as COVID.
- 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.
Show all 11Show fewer
- Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to Baseline.
- 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.
- 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.
- Lack of adequate venous access.
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, 33316
Midway Immunology and Research Center (MIRC)
Ft. Pierce, Florida, 34982
The Crofoot Research Center, Inc.
Houston, Texas, 77098
CAN Community Health Las Vegas
Las Vegas, Nevada, 89104
CAN Community Health Miami Gardens
Miami Gardens, Florida, 33055
The Rockefeller University
New York, New York, 10065
Midland Medical
Oakland Park, Florida, 33334
Orlando Immunology Center
Orlando, Florida, 32803
Quest Clinical Research
San Francisco, California, 94115
CAN Community Health Sarasota
Sarasota, Florida, 34237
About this study
Official title: 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
TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 48 weeks.
Researchers will compare TMB-365/TMB-380 given IV every 8 weeks to continuation of daily oral cART to see if TMB-365/TMB-380 can also maintain viral suppression.
Participants will:
- Receive TMB-365/TMB-380 infusion or take oral cART as scheduled for 48 weeks
- Visit the clinic as schedule for checkups and tests
- Conditions
- HIV -1 Infection
- Being tested
- TMB-365, TMB-380, Baseline ART
- Keywords
- HIV-1 maintenance treatment, HIV switch therapy, Broadly neutralizing antibody (bNAb), HIV post-attachment inhibitor, monoclonal antibody (mAb)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMB-365Drug
A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously
TMB-380Drug
Also called VRC07-523LS
A broadly neutralizing antibody (bNAb) against HIV to be given intravenously
Baseline ARTDrug
Baseline ART to be taken daily and orally
| Study group | Role | What they receive |
|---|---|---|
| Combination of TMB-365 and TMB-380 antibodies via IV infusions | Experimental | Participants will receive an IV infusion of the combination of TMB-365 and TMB-380 each every 8 weeks. Receives: Drug: TMB-365; Drug: TMB-380 |
| Baseline oral cART | Active comparator | Participants will continue suppressive daily oral cART Receives: Drug: Baseline ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral activity of TMB-365 and TMB-380 as maintenance therapy compared to daily oral cART
% of subjects with plasma HIV-1 RNA greater than or equal to 50 c/mL at week 48 by snapshot analysis as defined by US FDA
Measured: Week 48
Secondary outcomes (5)
Number of participants who experience protocol-defined virologic failure
Virologic failure is defined as two consecutive plasma HIV-1 RNA levels ≥200 copies/mL obtained at least 2 weeks apart.
Measured: 48 weeks
Pharmacokinetic profile of TMB-365
Mean trough concentrations for TMB-365 in Experimental Arm
Measured: Week 48
Pharmacokinetic profile of TMB-380
Mean trough concentrations for TMB-380 in Experimental Arm
Measured: Week 48
Safety of maintenance treatment regimen
Number of participants experience grade 3, grade 4, or serious adverse reactions related study treatment.
Measured: 48 weeks
Immune effects of maintenance therapy
Changes in CD4+ cell counts (cells/mm3) from baseline to Week 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start16 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiMed Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215468
- Sponsor's protocol ID
- TMB-b21
- Acronym
- VISTA
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07215468
- Acronym / sponsor ID
- VISTA / TMB-b21
- Conditions
- HIV -1 Infection
- Keywords
- HIV-1 maintenance treatment, HIV switch therapy, Broadly neutralizing antibody (bNAb), HIV post-attachment inhibitor, monoclonal antibody (mAb)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- TaiMed Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 48 weeks.
Researchers will compare TMB-365/TMB-380 given IV every 8 weeks to continuation of daily oral cART to see if TMB-365/TMB-380 can also maintain viral suppression.
Participants will:
- Receive TMB-365/TMB-380 infusion or take oral cART as scheduled for 48 weeks
- Visit the clinic as schedule for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of TMB-365 and TMB-380 antibodies via IV infusions | Experimental | Drug: TMB-365, Drug: TMB-380Participants will receive an IV infusion of the combination of TMB-365 and TMB-380 each every 8 weeks. |
| Baseline oral cART | Active comparator | Drug: Baseline ARTParticipants will continue suppressive daily oral cART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- At least 18 years of age on the day of Screening.
- 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.
- 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.
- Screening plasma HIV-1 RNA < 50 copies/mL
- CD4+ T cell count >350 cells/mm3
Key exclusion criteria (11 listed)
- History of receipt of any monoclonal antibody for any treatment, including bNAbs, whether naturally occurring, such as VRC01, or modified, such as VRC07-523LS.
- History of receipt of any long-acting ARV for treatment or prevention of HIV (investigational and commercial), including but not limited to cabotegravir/rilpivirine combination, lenacapavir, and islatravir.
- Pregnant, planning a pregnancy during the trial period, or lactating.
- Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation, or known allergy to a MAb.
- History of severe allergic reactions to medications, vaccinations, or monoclonal antibody therapy for other conditions such as COVID.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMB-365A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously | Drug | Combination of TMB-365 and TMB-380 antibodies via IV infusions |
| TMB-380Also: VRC07-523LSA broadly neutralizing antibody (bNAb) against HIV to be given intravenously | Drug | Combination of TMB-365 and TMB-380 antibodies via IV infusions |
| Baseline ARTBaseline ART to be taken daily and orally | Drug | Baseline oral cART |
Primary outcome
Antiviral activity of TMB-365 and TMB-380 as maintenance therapy compared to daily oral cART
Time frame: Week 48
% of subjects with plasma HIV-1 RNA greater than or equal to 50 c/mL at week 48 by snapshot analysis as defined by US FDA
5 secondary outcomes
Number of participants who experience protocol-defined virologic failure
Time frame: 48 weeks
Pharmacokinetic profile of TMB-365
Time frame: Week 48
Pharmacokinetic profile of TMB-380
Time frame: Week 48
Safety of maintenance treatment regimen
Time frame: 48 weeks
Immune effects of maintenance therapy
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for HIV -1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMB-365, TMB-380 and Baseline ART in people with HIV -1 Infection, run by TaiMed Biologics Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiviral activity of TMB-365 and TMB-380 as maintenance therapy compared to daily oral cART (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.