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

NCT07851337 | Not Yet Recruiting Phase 2

• 1 other identifier: ANRS 0766s GEODE
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV - Human Immunodeficiency Virus

Keywords

HIV; glatiramer acetate; IMMUNOTHERAPY

Outcome Measures

Primary Outcomes (1)

• 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).

  16Weeks

Study Arms (2)

Arm A (24 participants) : GLATIRAMER VIATRIS 40mg/ml

EXPERIMENTAL

Participants will receive GA via subcutaneous injections (40 mg/ml), three times a week, for 16 weeks in addition to their current antiretroviral treatment.

Drug: - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml

Arms B (12 participants) : control

NO INTERVENTION

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

Interventions

- Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml DRUG

Participants 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.

Arm A (24 participants) : GLATIRAMER VIATRIS 40mg/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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,
• Informed and written consent signed by the participant and the investigator (no later than the day of the enrolment visit and prior to any examination to be carried out as part of the trial) (Article L1122-1-1 of the Public Health Code),
• Participant covered by health insurance (Article L1121-11 of the Public Health Code).

You may not qualify if:

• 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,
• Current treatment with immunosuppressants, or during the 12 weeks prior to randomisation,
• History of chemotherapy or radiation therapy (any date),
• History of hematologic disorders (e.g. lymphoma, leukemia, Bone marrow transplant, solid organ transplant),
• History of cancer (except cancer that was cured by surgery alone more than 5 years ago; cutaneous epidermoid carcinoma; carcinoma in situ; Kaposi sarcoma that resolved without chemotherapy or radiation therapy),
• Chronic hepatitis B (positive HBs antigen) or hepatitis C (positive HCV RNA); cirrhosis (including non-viral causes),
• Active opportunistic infections with risk of severe immune reconstitution inflammatory syndrome (tuberculous neuromeningitis or cryptococcal neuromeningitis),
• Pregnancy or intention to be pregnant during the study period
• Participation in any other clinical trial of an investigational agent or in any interventional or non-interventional study requiring additional blood sampling. Participation in an observational study without additional blood sampling is permitted.
• Participants under guardianship or curatorship or under judicial protection,
• Renal failure : eGFR \< 30 mL/min/1.73 m² (CKD-EPI formula)

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09