T-cell Responses to Concurrent HIV and Herpesvirus Infections

NCT03996018 | Completed

• 1 other identifier: TORCH
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study in which we are trying to discover new information about how HIV and herpes viruses interact with the immune system. The goal of the study is to learn more about how T-cells in your immune system respond to and fight off long-term (chronic) viruses, in order to improve medical care in the future.

Conditions

HIV; HIV Infections

Outcome Measures

Primary Outcomes (1)

• HIV-1 specific TCR repertoire: Change in Simpson's diversity index over time

  using separated PBMCs, HIV-1 specific T-cells will be labeled with major histocompatibility complex (MHC) I tetramers previously described to be specific for HIV-1 \[14-18\]. Labeled cells will be subjected to flow cytometry for identity confirmation via established antibody cell marker staining, counting and sorting into single cells. The TCR genes of the individually sorted HIV-1 tetramer positive T-cells will then be sequenced, establishing a repertoire of TCR sequences. Diversities of the TCR gene repertoires obtained from each study group will be assessed using the established algorithm for Simpson's diversity index \[9\].

  0, 6, 12 and 18 months (+/- 30 days for all time points after 0).

Secondary Outcomes (5)

• Herpesvirus specific TCR repertoire: Change in Simpson's diversity index

  0, 6, 12 and 18 months (+/- 30 days for all time points after 0).

• T-Cell exhaustion: binary value (Exhausted/not exhausted)

  0, 6, 12 and 18 months (+/- 30 days for all time points after 0

• HIV control: HIV viral load

  0, 6, 12 and 18 months (+/- 30 days for all time points after 0

• Presence of herpesvirus infections: IgM and IgG levels

  0, 6, 12 and 18 months (+/- 30 days for all time points after 0

• HLA typing

  baseline

Study Arms (2)

group 1(HIV Uninfected)

Participant is HIV negative per antibody screen conducted on premises and participant is enrolled on HPTN 083 study

Other: T-cell lymphocyte responses

group 2 (HIV Infected)

Participant has initiated ART therapy as a patient at St Jude Children's Research Hospital, newly diagnosed HIV and prolonged HIV

Other: T-cell lymphocyte responses

Interventions

T-cell lymphocyte responses OTHER

T-cell lymphocyte responses to human immunodeficiency virus (HIV) with and without concomitant herpesvirus infections (specifically, the persistence of HIV-specific human CD8 T-cells in the context of antiretroviral therapy (ART).

group 1(HIV Uninfected); group 2 (HIV Infected)

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

Adults with HIV who meet eligibility criteria.

You may qualify if:

• Criteria • Participant is greater than or equal to 18 years of age.
• Group 1 (HIV Uninfected) Only
• Participant is HIV negative per antibody screen conducted on premises
• Participant is enrolled on HPTN 083 study (receiving HIV-PrEP) (see Recruitment and Screening).
• Group 2 (HIV Infected) Only
• Participant has initiated ART therapy as a patient at St Jude Children's Research Hospital
• \*Note: participants will be allowed to continue on study and have data analyzed regardless of presence of detectable HIV or CD4+ counts.
• a) Newly diagnosed HIV
• Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis within 90 days prior to enrollment
• b) Prolonged HIV
• Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis more than 365 days prior to enrollment

You may not qualify if:

• Participant is unable or unwilling to provide informed consent.
• If female of child bearing potential, participant has a positive urine pregnancy test at screening. Note: if participant becomes pregnant while on study, they may not continue on study.
• Concurrent enrollment on a research study or receiving treatment for concurrent medical diagnosis with any of the following interventions which may impact study outcomes: high dose or prolonged steroids, chemotherapy to treat malignancy, radiation therapy, biologic pharmaceutical treatments that induce immunosuppression.
• If in the opinion of the investigator, participation in the blood draw would endanger the health of the participant.
• Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Amanda Green, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 24, 2019
• Study Start: June 19, 2019
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

US (1)