NCT04160455Toboroz
Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 30.
Rövid összefoglaló (regiszter, angolul)
Little is known about autophagy during HIV infection. Recently, two different teams reported important dysfunctions of autophagy in HIV-infected patients despite sustained suppressive antiretroviral therapy. As altered autophagy is strongly linked to cellular senescence and chronic inflammation, two hallmarks of HIV-infected patients despite long-term suppressive antiretroviral therapy, it is important to improve our knowledge in the area. Our main objective is to determine whether all or part of mononuclear cell subpopulations (CD4+ and CD8+ T lymphocytes, and monocytes) exhibit a defect in autophagy function in a cohort of HIV-infected patients who are virologically-controlled (plasma HIV RNA <50 copies / ml) either spontaneously (i.e. HIV controllers or post-treatment controllers) or after they started antiretroviral therapy at different time points (i.e. at the acute or chronic phases), as compared with a control group (i.e. uninfected healthy blood donors).
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 180 (tervezett)
- Első benyújtás
- 2019. nov. 8.
- Kezdés
- 2019. nov. 7.
- Elsődleges befejezés
- 2029. nov. 7.
- Fő szponzor
- Centre Hospitalier Régional d'Orléans
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT04160455
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 180
- 2019. nov. 7. és az elsődleges befejezés (2029. nov. 7.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Treatment with oral or injectable anticoagulant (curative or preventive)
Más betegség
- Patient with a history of inflammatory bowel disease, malignancy, intestinal ischemia, malabsorption or other gastrointestinal dysfunction that, in the judgment of the investigator, could interfere with the interpretation of the results.
- Presence of coagulation abnormality or unexplained bleeding history
Egyéb
- Patient unable, according to the investigator, to meet the requirements of the protocol
- Pregnant or lactating woman
- Patient covered by Article L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (including minors and protected adults)
- Patient under guardianship or curatorship
- Patient who uncovered by French health insurance Patient participating in another clinical trial, evaluating a treatment
Kiket keres a vizsgálat
- General criteria:
- Age >=18 years
- Man or woman
- Infected with HIV-1 (and not co-infected with HIV-2)
- Followed at Orleans' Regional Hospital
- Patient belonging to one of the predefined cohorts/groups (see below)
- Patient having provided a written consent
- Specific profiles of HIV-infected patients for the ATGALIG-HIV study:
- Cohort A: patients on suppressive antiretroviral therapy (HIV RNA <50 copies / ml for at least 4 years) initiated during the chronic phase, divided into 2 groups according to the following criteria:
- group A1: CD4 count less than 500 cells / ml at the time of inclusion in the study
- group A2: CD4 count above 500 cells / ml at the time of inclusion in the study Cohort B: patients on suppressive antiretroviral therapy (HIV RNA <50 copies / ml for at least 4 years) initiated since the primary-infection (within 4 months after acute infection)
- Cohort C: patients with detectable HIV RNA, naïve of antiretroviral, but who have an indication to start antiretroviral therapy, divided into the following 3 groups:
- group C1: HIV diagnosis made during primary infection (within 4 months of infection)
- group C2: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count above 200 cells/ml at the time of inclusion in the study
- group C3: HIV diagnosis made during the chronic phase (more than 1 year after contamination), with CD4 count less than 200 cells/ml at the time of inclusion in the study Cohort D: patients who have undetectable plasma HIV RNA (HIV RNA <50 copies / ml ) without antiretroviral therapy, either spontaneously (HIV controllers or elite controllers) or after treatment interruption (post-treatment controllers)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHU Orléans | Orléans | Franciaország | Toboroz |
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