HIV Persistence in Lymph Node and Peripheral Blood

NCT03426189 | Completed

• 1 other identifier: 1646930
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to determine whether latent HIV is enriched in cells expressing certain proteins (receptors) on their surface and whether it is possible to eliminate these cells through the use of drugs that specifically target these proteins. Lymph nodes are known to contain very high numbers of HIV infected cells.

Conditions

HIV-1-infection

Keywords

HIV; Latent reservoir; Leukapheresis; Inguinal lymph node biopsy; Immune checkpoint; PD1; CTLA4

Outcome Measures

Primary Outcomes (1)

• Frequency of HIV-1 in cells expressing CTLA4 and PD-1 in lymph node derived cells

  Baseline only

Secondary Outcomes (2)

• Frequency of HIV-1 in cells expressing CTLA4 and PD-1 in blood derived cells

  Baseline only

• Change in interferon gamma production in HIV specific T-cells following ex vivo blockade of PD-1 and CTLA4

  Baseline only

Study Arms (1)

HIV infected individuals on long term ART

* Leukapheresis * Lymph node biopsy

Procedure: Leukapheresis; Procedure: Lymph node biopsy

Interventions

Leukapheresis PROCEDURE

Blood will be taken by a needle inserted into a vein in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out of the machine for purposes of this research. The rest of the blood will be returned through a needle in the other arm.

HIV infected individuals on long term ART

Lymph node biopsy PROCEDURE

Ultrasound will be used to localize the position of one lymph node in the groin. Under a light general anesthetic, one lymph node will be removed.

HIV infected individuals on long term ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected individuals on long term antiretroviral therapy

You may qualify if:

• Written Informed Consent
• Willing to undergo leukapheresis and lymph node biopsy
• Documented HIV-1 infection (antibody positive or detectable plasma HIV-1 RNA)
• Receiving combination ART
• HIV RNA \< 50 copies/mL for \> 3 years (Episodes of a single HIV plasma RNA 50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was \<50 copies/mL)

You may not qualify if:

• Unwillingness to follow protocol requirements
• Contraindications to LN biopsy or leukapheresis
• Current skin infection of inguinal area
• Known current lower extremity, gastrointestinal or genitourinary infection

Sponsors & Collaborators

• University of Melbourne: lead
• amfAR, The Foundation for AIDS Research: collaborator
• University of California, San Francisco: collaborator
• Monash University: collaborator
• Université de Montréal: collaborator
• The Avenue Hospital: collaborator
• Oregon Health and Science University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood (CD4+ T cells, CD8+ T cells; plasma) * Lymph node biopsy (CD4+ T cells, CD8+ T cells)

MeSH Terms

Interventions

Leukapheresis; Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Biopsy; Cytodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision

Study Officials

• Sharon Lewin

  The Peter Doherty Institute for Infection and Immunity, University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, The Peter Doherty Institute for Infection and Immunity

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: February 8, 2018
• Study Start: January 2, 2017
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

AU (1)