Clinical trial NCT03996018: T-cell Responses to Concurrent HIV and Herpesvirus Infections
Official title: T-cell Responses to Concurrent HIV and Herpesvirus Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
HIV Infections
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with HIV who meet eligibility criteria.

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.

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).

Primary outcomes:
measure: HIV-1 specific TCR repertoire: Change in Simpson's diversity index over time
timeFrame: 0, 6, 12 and 18 months (+/- 30 days for all time points after 0).
Secondary outcomes:
measure: Herpesvirus specific TCR repertoire: Change in Simpson's diversity index
timeFrame: 0, 6, 12 and 18 months (+/- 30 days for all time points after 0).
measure: T-Cell exhaustion: binary value (Exhausted/not exhausted)
timeFrame: 0, 6, 12 and 18 months (+/- 30 days for all time points after 0
measure: HIV control: HIV viral load
timeFrame: 0, 6, 12 and 18 months (+/- 30 days for all time points after 0
measure: Presence of herpesvirus infections: IgM and IgG levels
timeFrame: 0, 6, 12 and 18 months (+/- 30 days for all time points after 0
measure: HLA typing
timeFrame: baseline
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Amanda Green, MD
role: PRINCIPAL_INVESTIGATOR
References: