Clinical trial NCT04305665: HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection
Official title: HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hiv
Keywords: HIV
Latency
Latency reversing agents
Latency reversal
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-03-12
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-1 positive persons

Brief summary: The aim of this study is to gain new insights into HIV latency and reversal through extensive blood and tissues sampling (lymph node and colon biopsies) from 25 individuals under ART.


Eligibility criteria: Inclusion Criteria:

* Documented HIV-1 subtype B infection
* Able and willing to provide written informed consent
* Age = or \>18 years and \< 65 years
* CD4 count at screening \> 350/μl
* Viral load \< 40 copies/ml determined by CobasTaqMan HIV-1 test v2.0 assay for at least 2 years (one blip \< 200 copies/ml is allowed)
* Ability and willingness to have blood and tissue samples collected and stored for 20 years and used for various research purposes.

Exclusion Criteria:

* Previous or 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 or known history of cancer.
* History of HIV-related thrombocytopenia.
* Pregnancy or breastfeeding.
* Any conditions, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
* Previous participation in a trial evaluating an immune modulating agent.
* 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 HIV DNA and 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: Transcriptome analysis
timeFrame: 5 years
measure: High dimensional phenotyping
timeFrame: 5 years
measure: Immunohistochemistry, RNA- and DNA In Situ Hybridization
timeFrame: 5 years
measure: Extracellular vesicles analysis
timeFrame: 5 years
measure: Immunometabolic profile analysis
timeFrame: 5 years
measure: p24 quantification
timeFrame: 5 years
measure: Detection of translation-competent reservoirs
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Linos Vandekerckhove, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: