Analysis of the Reservoir in Individuals Controlling HIV Infection

Обзор

The aim of this study is the gain new insights into HIV latency in HIV controllers through extensive blood an tissue sampling (lymph node, colon biopsies, placenta) from 25 individuals living with HIV and healthy individuals.

Вмешательства

• Диагностический тест HIV Latency Diagnostic Sampling
  This intervention involves the collection of blood, lymph node, colon biopsy, and placental samples from individuals living with HIV (HIV controllers) and healthy controls. The goal is to investigate HIV latency by analyzing these biological samples to gain insights into the mechanisms and characteristics of latent HIV reservoirs. The sampling procedures will be conducted using minimally invasive techniques where appropriate, and the collected samples will undergo laboratory analysis for further

Первичные конечные точки

• Quantification of total and intact HIV DNA and HIV RNA [Срок оценки: 5 years]
• Integration site analysis [Срок оценки: 5 years]
• Full-length HIV genome analysis [Срок оценки: 5 years]
• Epigenetic analysis [Срок оценки: 5 years]
• Matched integration site and proviral sequencing [Срок оценки: 5 years]
• Proviral UMI-mediated Long-read Sequencing [Срок оценки: 5 years]
• Transcriptome analysis [Срок оценки: 5 years]
• High dimensional phenotyping [Срок оценки: 5 years]
• Immunohistochemistry, RNA- and DNA In Situ Hybridization [Срок оценки: 5 years]
• Immunometabolic profile analysis [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Elite Controllers: pVL<50 copies per ml for at least 12 months, treatment naive at the time of inclusion
• Viral controllers: pVL <2000 copies/ml; CD4>500/µL for at least two years, treatment naïve at the time of inclusion
• Long-term non-progressors: CD4>500/µL, pVL <10000 copies/ml, for at least 7 years, treatment naïve at the time of inclusion
• Post treatment controllers: on cART for at least 12 months; pVL <500 copies/ml for at least 2 years after treatment cessation .
• PLWH who received bone marrow transplant: people living with HIV who received a bone-marrow transplant for non-HIV related reasons

Критерии исключения

• Current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
• Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (= HBV antigen or viral load negative and positive HBV surface antibody)).
• Evidence of active HCV infection (HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry).
• Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
• Current history of cancer.
• History of HIV-related thrombocytopenia.
• Any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
• Abnormal results of standard of care laboratory tests:

• Confirmed haemoglobin <11g/dl for women and <12 g/dl for men
• Confirmed platelet count <100 000/µl \*
• Confirmed neutrophil count <1000/μl
• Confirmed AST and/or ALT >10xULN
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
• The following treatment will be prohibited three months before screening and during the study:

• immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use.
• Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06016114 · ID 12241 - ARCH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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