TMB-365 + TMB-380 for HIV
(VISTA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether two antibodies, TMB-365 and TMB-380, can maintain HIV control in individuals already managing the virus with daily oral medication. These antibodies block the virus from entering cells. Participants will either receive an infusion of these antibodies every eight weeks or continue their current daily medication for 48 weeks. Ideal candidates for this trial are individuals who have been living with HIV, have controlled it with daily medication for at least six months, and have low viral levels. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in HIV treatment.
Will I have to stop taking my current medications?
Yes, if you join this trial, you will need to stop your current oral cART (combination antiretroviral therapy) for 48 weeks to receive the TMB-365/TMB-380 treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using TMB-365 and TMB-380 together is safe. Studies found that a single dose of these two antibodies was well-tolerated, with participants experiencing no serious side effects. The treatment also kept the virus under control. Even at higher doses, TMB-365 and TMB-380 remained safe. This indicates that these antibodies are generally safe for people with HIV who are already managing the virus with other medications.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about TMB-365 and TMB-380 for HIV because they represent a new approach to treatment by using antibodies. Unlike the standard of care, which typically involves daily oral antiretroviral therapies (cART) targeting viral replication, these treatments are administered via IV infusions every eight weeks and leverage the body's immune response. This method offers the potential to improve adherence by reducing the frequency of doses and may provide a novel mechanism of action against HIV.
What evidence suggests that this trial's treatments could be effective for HIV?
In this trial, participants will receive a combination of TMB-365 and TMB-380 antibodies through IV infusions. Research has shown that this combination is promising for controlling HIV. Earlier studies demonstrated that these antibodies block HIV from entering cells, which is crucial for managing the virus. Data from past trials indicated that people using this combination kept the virus suppressed without needing special tests to determine its effectiveness for their type of HIV. Additionally, these treatments proved to be safe and effective as a long-lasting option. This suggests that TMB-365 and TMB-380 could be a suitable choice for those wanting to switch from daily pills.12356
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HIV who've been on continuous oral cART (a recommended HIV treatment regimen) for at least 6 months, have a viral load under 50 copies/mL, and normal organ function tests. They must have a CD4+ T cell count above 350 cells/mm3 and not have had any cART interruptions longer than three days.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TMB-365/TMB-380 infusion or continue oral cART for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TMB-365
- TMB-380
Trial Overview
The study is testing if two antibodies, TMB-365 and TMB-380 given intravenously every eight weeks can maintain HIV suppression in patients who stop taking their daily oral cART. This will be compared to those continuing the standard oral treatment for a period of 48 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive an IV infusion of the combination of TMB-365 and TMB-380 each every 8 weeks.
Participants will continue suppressive daily oral cART
Find a Clinic Near You
Who Is Running the Clinical Trial?
TaiMed Biologics Inc.
Lead Sponsor
Citations
A 24-Week Phase II Maintenance Study of TMB-365/ ...
This study was to evaluate the safety, efficacy, and PK of the TMB-. 365 and TMB-380 combination given as a single IV infusion in people with suppressed HIV.
TaiMed Biologics Announces its Long-Acting TMB-365/380 ...
This clinical study aims to evaluate the safety, efficacy, and pharmacokinetics profile of the long-acting TMB-365/TMB-380 combination as a ...
HIV-1 Virologic Suppression With TMB-365 and TMB-380 ...
Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals ...
TaiMed Biologics Announces Results from Late-Breaking ...
One of the more remarkable findings of TMB-365/TMB-380 is that it does not require susceptibility screening as the combination's broad breadth ...
TaiMed Biologics to Present Late-Breaking Phase IIa Data ...
The study results highlight the superior safety and efficacy profile of TMB-365/TMB-380—a first-of-its-kind long-acting dual bNAb regimen—for ...
A DOSE ESCALATION STUDY OF SAFETY & PK OF TMB- ...
A single infusion of TMB-365 and TMB-380 in combination up to 4800 mg each is safe. Prolonged PK duration was observed for both TMB-365 and TMB- ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.