Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy

What Was Tested

This registered phase 2 trial tested Glatiramer Acetate.

ANRS 0766s GEODE is a Pilot, multicenter, randomised and open-label clinical trial: Participants will be randomized 2:1 to either one of the two parallel arms * Arm A (24 participants) : Glatiramer Acetate (GA) * Arms B (12 participants) : control Randomisation of the trial arms: The participants will be randomised in an open-label trial in a 2:1 ratio with, for each arm, a distribution by age group (\< 50 and = or \> 50 years) using a minimisation randomisation method.

The trial will consist of three phases: Phase I: A first controlled phase in which participants in arm A will receive subcutaneous injections of GA three times a week for 16 weeks, and will be compared with participants randomised to arm B who do not receive GA (control group).

It had two arms (groups): one (experimental) and Arms B (12 participants) : control (no intervention).

Control group (Arm B): The participants will continue their current antiretroviral treatment.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Âge \> or = to 18 years,. Have a sustained HIV-1 plasma viral load \<50 copies/mL on ART for more than 3 years (blips \<400 copies/mL allowed),. Have a blood CD4 T cell count \<500 cells/μL (at the last three time points analyzed, including the screening visit, in the 18 months),. Have a blood CD4/CD8 T cell ratio \<0.5 (at the last three time points analyzed, including the screening visit, in the past 18 months),. Willing to receive treatment via subcutaneous injections three times a week, to adhere to the study schedule, and to accept blood samples in accordance with the protocol,.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: HIV-2 infection,; age \>65 years (to avoid lack of immune reconstitution due to immunosenescence),; hypersensitivity to glatiramer acetate or to its excipient: mannitol,.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2026-12-01 with completion listed for 2028-12-15.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in the CD4/CD8 ratio between W0 and W16 (intra-patient difference between the CD4/CD8 ratio at Week16 and Week0) (time frame: 16Weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 36 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, all human trials.