Loading clinical trials...

T-cell Responses to Concurrent HIV and Herpesvirus Infections | Clinical Trials | Clareo Health

COMPLETED

T-cell Responses to Concurrent HIV and Herpesvirus Infections

NCT03996018•St. Jude Children's Research Hospital

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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).

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Key Dates

Start Date

June 19, 2019

Primary Completion Date

July 28, 2023

Completion Date

July 28, 2023

Last Updated

November 15, 2024

Enrollment

135

ACTUAL participants

Conditions

HIVHIV Infections

Interventions

T-cell lymphocyte responses

OTHER

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

View study

RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

View study

RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

T-cell Responses to Concurrent HIV and Herpesvirus Infections

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption