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NCT06016114Not yet recruiting

Analysis of the Reservoir in Individuals Controlling HIV Infection

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
25 (estimated)
First submitted
23 Aug 2023
Start date
Dec 2024
Primary completion date
Oct 2028
Lead sponsor
University Hospital, Ghent
Diseases
HIV
NCT number
NCT06016114

What you commit to

  • Study type: Observational
  • Planned participants: 25
  • From Dec 2024 to the primary completion date, Oct 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • 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.

Other illness

  • 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)).
  • 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.

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.