Measuring HIV Latency and Reversal in Patients

HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection

This study is trying to learn more about hidden HIV in the body by taking blood and tissue samples from people who have been on treatment for a while and have low virus levels.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Ghent (Academic / other)
• Locations: 1 site (Ghent)
• Trial ID: NCT04305665 on ClinicalTrials.gov

What this trial studies

This observational study aims to gain insights into HIV latency and the potential for reversal by collecting extensive blood and tissue samples from 25 individuals undergoing antiretroviral therapy (ART). Participants will undergo lymph node and colon biopsies to analyze the cellular level of HIV reservoirs. The study focuses on individuals with documented HIV-1 subtype B infection who have maintained a low viral load for at least two years. The findings could enhance understanding of HIV persistence and inform future therapeutic strategies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with documented HIV-1 subtype B infection, a CD4 count above 350/μl, and a sustained viral load below 40 copies/ml.

Not a fit: Patients with a history of opportunistic infections or active hepatitis infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for curing HIV infection by targeting latent reservoirs.

How similar studies have performed: While studies on HIV latency and reversal have been conducted, this specific approach focusing on cellular measurement is relatively novel.

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.

Where this trial is running

Ghent

• Ghent University Hospital — Ghent, Belgium (Recruiting)

Study contacts

• Principal investigator: Linos Vandekerckhove, MD PhD — University Hospital, Ghent
• Study coordinator: Sofie Rutsaert

Conditions Hiv; HIV; Latency; Latency reversing agents; Latency reversal