Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ANRS, Emerging Infectious Diseases
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
