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

NCT ID: NCT04305665

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2025-12-31

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.

Conditions

Hiv

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV-1 positive persons

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linos Vandekerckhove, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Sofie Rutsaert

Role: CONTACT

sofierutsaert@hotmail.com

+32 9 332 06 98

Facility Contacts

Sofie Rutsaert

Role: primary

sofierutsaert@hotmail.com

+32 9 332 06 98

References

Delporte M, Lambrechts L, Blomme EE, van Snippenberg W, Rutsaert S, Verschoore M, De Smet E, Noppe Y, De Langhe N, De Scheerder MA, Gerlo S, Vandekerckhove L, Trypsteen W. Integrative Assessment of Total and Intact HIV-1 Reservoir by a 5-Region Multiplexed Rainbow DNA Digital PCR Assay. Clin Chem. 2025 Jan 3;71(1):203-214. doi: 10.1093/clinchem/hvae192.

Reference Type: DERIVED

PMID: 39749517 (View on PubMed)

Other Identifiers

BC-07056

Identifier Type: -

Identifier Source: org_study_id