The purpose of this trial is to evaluate the immunomodulatory effects of glatiramer acetate (GA) in improving the recovery of CD4 T cells and the CD4/CD8 ratio in people living with HIV (PLWHIV) who have poor immune recovery and persistent immune activation, despite virologically effective antiretroviral (ARV) treatment.
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). The primary endpoint will be assessed at week 16 (end of the controlled phase).
Phase II: A second post-interventional observational phase will begin after W16 to evaluate a potential post-treatment effect and its duration in arm A.
During this phase, the efficacy of the strategy during the phase I will be analysed for all participants (once the last randomised participant has reached week 16).
It will continue until the potential opening of the phase III extension, in the event of efficacy be confirmed, or until the decision to terminate the trial if this is not the case.
Phase III: An optional third extension phase may be offered to participants in both arms. The opening of this phase will be conditional upon prior demonstration of a global benefit between both treatment groups during Phase I. During this optional phase III, participants in arm A will be offered a second cycle of GA and those in arm B, a first cycle of GA at the same frequency as a subcutaneous injection three times a week for 16 weeks. Participation in this phase will be optional.
All participants will continue their current antiretroviral treatment.
Âge > or = to 18 years,
HIV-1 infection,
Receiving ART,
Have a sustained HIV-1 plasma viral load <50 copies/mL on ART for more than 3 years (blips <400 copies/mL allowed),
HIV-2 infection,
Age >65 years (to avoid lack of immune reconstitution due to immunosenescence),
Hypersensitivity to glatiramer acetate or to its excipient: mannitol,
Current treatment with systemic corticosteroids, or during the 12 weeks prior to randomisation,
Parallel
- Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml
DrugParticipants will receive GA via subcutaneous injections (40 mg/ml), three times a week, for 16 weeks in addition to their current antiretroviral treatment. The first injection will be administered in hospital under medical supervision. Subsequent injections will be self-administered by participants at home. An injection pen to facilitate subcutaneous injections will be provided to participants.
Change in the CD4/CD8 ratio between W0 and W16 (intra-patient difference between the CD4/CD8 ratio at Week16 and Week0).
Change in the CD4/CD8 ratio between Week0 and Week16 (intra-patient difference between the CD4/CD8 ratio at Week16 and Week0).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
