HIV - Human Immunodeficiency VirusPhase 2GEODENCT07851337
Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy
A Phase 2 study testing - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml in people with HIV - Human Immunodeficiency Virus, run by ANRS, Emerging Infectious Diseases.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV - Human Immunodeficiency Virus
- What is being tested?
- - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 15 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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).
Who cannot join
- 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),
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- 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)
About this study
Official title: Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy: a Phase II, Multicenter, Randomized, Open-label, Pilot Clinical Trial
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:
Read more
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
- Being tested
- - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml
- Keywords
- HIV, glatiramer acetate, IMMUNOTHERAPY
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/mlDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851337
- Sponsor's protocol ID
- ANRS 0766s GEODE
- Acronym
- GEODE
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy: a Phase II, Multicenter, Randomized, Open-label, Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07851337
- Acronym / sponsor ID
- GEODE / ANRS 0766s GEODE
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- HIV, glatiramer acetate, IMMUNOTHERAPY
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (24 participants) : GLATIRAMER VIATRIS 40mg/ml | Experimental | Drug: - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/mlParticipants will receive GA via subcutaneous injections (40 mg/ml), three times a week, for 16 weeks in addition to their current antiretroviral treatment. |
| Arms B (12 participants) : control | No intervention | –Control group (Arm B): The participants will continue their current antiretroviral treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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),
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/mlParticipants 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. | Drug | Arm A (24 participants) : GLATIRAMER VIATRIS 40mg/ml |
Primary outcome
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
Change in the CD4/CD8 ratio between Week0 and Week16 (intra-patient difference between the CD4/CD8 ratio at Week16 and Week0).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing - Study treatment arm group (Arm A): GLATIRAMER VIATRIS 40mg/ml in people with HIV - Human Immunodeficiency Virus, run by ANRS, Emerging Infectious Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.