AGT103-T for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gene and cell therapy called AGT103-T for people with HIV. The main goal is to determine if this treatment is safe for those whose HIV is well-controlled with antiretroviral therapy (ART). Participants will receive either a high or low dose of specially modified T cells, a type of immune cell. People who have had HIV for 3 or more years and have kept it under control with ART might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires participants to continue their current antiretroviral regimen unless a change is medically necessary. However, certain medications like Selzentry (Maraviroc), protease inhibitors, efavirenz, and zidovudine are not allowed.
Is there any evidence suggesting that AGT103-T is likely to be safe for humans?
Research has shown that AGT103-T was well tolerated by participants in earlier studies. Both low and high doses of this treatment were tested, and results indicated general safety. No serious side effects were reported, and participants managed the treatment well. AGT103-T is a gene and cell therapy designed to help the immune system fight HIV more effectively. Although the treatment remains in early testing stages, the initial safety data appears promising for those considering participation.12345
Why do researchers think this study treatment might be promising?
Unlike the standard antiretroviral therapies for HIV, which work by suppressing the virus, AGT103-T is a gene and cell therapy that aims to modify the body's own immune cells to fight the virus directly. This approach uses genetically modified T cells intended to provide a long-term solution by potentially eradicating the virus from the body or significantly reducing its presence. Researchers are excited about AGT103-T because it could offer a more durable and potentially curative treatment for HIV, moving beyond the need for lifelong medication adherence and the challenges associated with it.
What evidence suggests that AGT103-T might be an effective treatment for HIV?
Research has shown that AGT103-T could be promising in treating HIV. This trial will evaluate two different dosing cohorts of AGT103-T. Studies have found that this treatment can boost the body's immune response against HIV, leading to a noticeable and lasting decrease in the virus in the body. In trials, all participants experienced a significant drop in the virus's genetic material that can cause infection. The treatment involves infusing specially modified immune cells back into the body to help fight the virus more effectively. These early results suggest that AGT103-T could effectively control HIV in people already using antiretroviral therapy.15678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single infusion of genetically modified T cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGT103-T
How Is the Trial Designed?
A single infusion of ≥1x10e8 and \<1x10e9 genetically modified T cells.
A single infusion of ≥1x10e9 and \<5x10e9 genetically modified T cells.
Find a Clinic Near You
Who Is Running the Clinical Trial?
American Gene Technologies International Inc.
Lead Sponsor
Citations
Safety and durability of AGT103-T autologous T cell ...
AGT103-T at low or high doses was safe and effective for improving host T cell immunity to HIV. Further studies, including antiretroviral ...
HIV Cure Countdown
Two analytical interventions demonstrate that AGT103-T can support an effective immune response to HIV, resulting in a substantial and durable reduction in ...
American Gene Technologies announces promising ...
All evaluable patients demonstrated a significant reduction in Intact Proviral HIV DNA following treatment with AGT103-T.
Genetic Engineering & Biotechnology News: AGT Spins ...
“Our results indicate that AGT103-T cell product infusion altered antiviral immunity in trial participants and transiently increased Gag- ...
American Gene Technologies Announces Promising ...
In all five evaluable participants, AGT103-T resulted in a significant decrease in intact HIV proviral DNA in blood. · One subject's reservoir ...
Our Approach to an HIV Cure | HIV Gene Therapy
We conducted a Phase 1a clinical study that evaluated the safety and durability of AGT103-T in seven people living with HIV. We also sought to evaluate the ...
NCT04561258 | Study to Evaluate the Safety of a Gene ...
This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor lymphocyte infusion in HIV+ participants with well-controlled ...
8.
americangene.com
americangene.com/blog/phase-1-hiv-clinical-trial-data-published-in-frontiers-in-medicine-journal/AGT's AGT103-T Phase 1 HIV Clinical Trial Data Published ...
Our data indicates that both low and high doses of AGT103-T were well tolerated by trial participants, the infused helper T cells can coordinate ...
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