AGT103-T for HIV

No longer recruiting at 3 trial locations
AM
Overseen ByAnisha Mannan
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: American Gene Technologies International Inc.
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

CD4 T cell count >400 cells/mm3
Documented HIV infection for ≥3 years
Platelet count ≥150,000/mm3
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of genetically modified T cells

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • AGT103-T
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Low Dose CohortExperimental Treatment1 Intervention
Group II: High Dose CohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

American Gene Technologies International Inc.

Lead Sponsor

Trials
4
Recruited
50+

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 CountdownTwo 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 TherapyWe 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 ...
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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