Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy

Recruiting at 1 trial location

Overseen By Anisha Mannan

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: American Gene Technologies International Inc.

Must be taking: Antiretrovirals

Must not be taking: Protease inhibitors, Efavirenz, Zidovudine, others

Disqualifiers: Hepatitis, Cancer, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment where a patient's own immune cells are modified to better fight HIV. It targets people with HIV who have their virus under control with medication.

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.

Eligibility Criteria

Inclusion Criteria

CD4 T cell count >400 cells/mm3

Male or female between 18-60 years

Documented HIV infection for ≥3 years

Timeline

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)

Treatment Details

Interventions

• AGT103-T

Participant Groups

Group I: Low Dose Cohort Experimental Treatment 1 Intervention

A single infusion of ≥1x10e8 and \<1x10e9 genetically modified T cells.

Group II: High Dose Cohort Experimental Treatment 1 Intervention

A single infusion of ≥1x10e9 and \<5x10e9 genetically modified T cells.

Who Is Running the Clinical Trial?

American Gene Technologies International Inc.

Lead Sponsor

Trials

4

Recruited

50+