NCT07851337Toborzás még nem indult2. fázis
Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy
Immunotherapy With Glatiramer Acetate in PLWHIV in Poor Immunological Responders on Antiretroviral Therapy: a Phase II, Multicenter, Randomized, Open-label, Pilot Clinical Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 1.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 36 (tervezett)
- Első benyújtás
- 2026. szept. 1.
- Kezdés
- 2026. dec. 1.
- Elsődleges befejezés
- 2028. dec. 15.
- Fő szponzor
- ANRS, Emerging Infectious Diseases
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT07851337
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 36
- 2026. dec. 1. és az elsődleges befejezés (2028. dec. 15.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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,
- 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.
Más betegség
- HIV-2 infection,
- Hypersensitivity to glatiramer acetate or to its excipient: mannitol,
- 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),
Laborértékek
- Renal failure : eGFR < 30 mL/min/1.73 m² (CKD-EPI formula)
Életkor
- Age >65 years (to avoid lack of immune reconstitution due to immunosenescence),
Egyéb
- Pregnancy or intention to be pregnant during the study period
- Participants under guardianship or curatorship or under judicial protection,
Kiket keres a vizsgálat
- 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).
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