Analysis of the Reservoir in Individuals Controlling HIV Infection

NCT ID: NCT06016114

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2028-10-01

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.

Conditions

Hiv

Study Design

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

Study Groups

HIV-1 positive individuals (non-pregnant)

HIV Latency Diagnostic Sampling

Intervention Type: DIAGNOSTIC_TEST

This intervention involves the collection of blood, lymph node, colon biopsy, and placental samples from individuals living with HIV (HIV controllers) and healthy controls. The goal is to investigate HIV latency by analyzing these biological samples to gain insights into the mechanisms and characteristics of latent HIV reservoirs. The sampling procedures will be conducted using minimally invasive techniques where appropriate, and the collected samples will undergo laboratory analysis for further study.

Pregnant HIV-1 positive/negative individuals

HIV Latency Diagnostic Sampling

Intervention Type: DIAGNOSTIC_TEST

This intervention involves the collection of blood, lymph node, colon biopsy, and placental samples from individuals living with HIV (HIV controllers) and healthy controls. The goal is to investigate HIV latency by analyzing these biological samples to gain insights into the mechanisms and characteristics of latent HIV reservoirs. The sampling procedures will be conducted using minimally invasive techniques where appropriate, and the collected samples will undergo laboratory analysis for further study.

Interventions

HIV Latency Diagnostic Sampling

This intervention involves the collection of blood, lymph node, colon biopsy, and placental samples from individuals living with HIV (HIV controllers) and healthy controls. The goal is to investigate HIV latency by analyzing these biological samples to gain insights into the mechanisms and characteristics of latent HIV reservoirs. The sampling procedures will be conducted using minimally invasive techniques where appropriate, and the collected samples will undergo laboratory analysis for further study.

Intervention Type: DIAGNOSTIC_TEST

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.

• 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

Central Contacts

Klara Dewitte

Role: CONTACT

klara.dewitte@ugent.be

+32 9 332 06 98

Other Identifiers

ID 12241 - ARCH

Identifier Type: -

Identifier Source: org_study_id