Clinical trial NCT06016114: Analysis of the Reservoir in Individuals Controlling HIV Infection
Official title: Analysis of the Reservoir in Individuals Controlling HIV Infection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hiv
Keywords: HIV
Latency
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-positive individuals (pregnant and non-pregnant) and pregnant HIV-negative individuals

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. Confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men
  2. Confirmed platelet count \<100 000/µl \*
  3. Confirmed neutrophil count \<1000/μl
  4. 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:

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

Primary outcomes:
measure: Quantification of total and intact HIV DNA and HIV RNA
timeFrame: 5 years
measure: Integration site analysis
timeFrame: 5 years
measure: Full-length HIV genome analysis
timeFrame: 5 years
measure: Epigenetic analysis
timeFrame: 5 years
measure: Matched integration site and proviral sequencing
timeFrame: 5 years
measure: Proviral UMI-mediated Long-read Sequencing
timeFrame: 5 years
measure: Transcriptome analysis
timeFrame: 5 years
measure: High dimensional phenotyping
timeFrame: 5 years
measure: Immunohistochemistry, RNA- and DNA In Situ Hybridization
timeFrame: 5 years
measure: Immunometabolic profile analysis
timeFrame: 5 years
measure: Detection of translation-competent reservoirs
timeFrame: 5 years
measure: Immunological analysis-FACS
timeFrame: 5 years
measure: Immunological analysis-ELISA
timeFrame: 5 years
measure: Microbiome monitoring
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Linos Vandekerckhove, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: