T-cell Responses to Concurrent HIV and Herpesvirus Infections

NCT ID: NCT03996018

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2023-07-28

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.

Detailed Description

HIV-uninfected & HIV-infected participants who enroll on this study will be asked to provide blood samples for 18 months. These samples will be used to assess T-cell responses and presence of herpesvirus(es).

Primary Objective

Characterize phenotypic and functional features, including TCR repertoires of HIV-specific CD8 T-cell responses and exhaustion in HIV-positive humans with and without concomitant herpesvirus infections.

Conditions

HIV; HIV Infections

Study Design

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

Study Groups

group 1(HIV Uninfected)

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

T-cell lymphocyte responses

Intervention Type: 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 2 (HIV Infected)

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

T-cell lymphocyte responses

Intervention Type: 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).

Interventions

T-cell lymphocyte responses

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

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

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Green, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

TORCH

Identifier Type: -

Identifier Source: org_study_id