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HIV InfectionsNCT03215004

Developing a Functional Cure for HIV Disease: Clinical Specimen Collection From HIV Positive Individuals

An observational study of HIV Infections, run by American Gene Technologies International Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clinical specimens are required from HIV positive individuals with viremia controlled by antiretroviral therapy to complete process development for a genetically modified autologous T cell product, AGT103-T. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV Infections
How many people
24 participants
Where
2 sitesUnited States
Study dates
25 Jul 2017to 7 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Individuals with chronic, persistent HIV disease that is well-controlled by combination antiretroviral therapy

Who may be able to join

  • Male or female aged between ≥18 and ≤60 years
  • Documented HIV infection for at least 3 years prior to study entry
  • Stable on HIV antiretroviral regimen with viral suppression to <50c/mL plasma for >2 years
  • Agrees not to change antiretroviral regimen (unless medically indicated) during the study period
  • CD4+ T cell count >500 cell per millimeter cubed (cells/mm3) at last measurement within 6 months of study participation
  • CD4+ T cell nadir of >350 cells/mm3
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  • HIV plasma viral load <50 copies of viral RNA per milliliter (mL) for >2 years
  • Participants who had intermittent, isolated episodes of detectable low-level viremia (<500c/mL; blips) will remain eligible.
  • Have not received cytoreduction therapy within 3 months of study entry
  • Do not have prior events of hemorrhagic cystitis
  • Is not being treated or does not have bacteremia within the past 6 months
  • Does not have signs or symptoms of acute infectious disease
  • Adequate venous access and no other contraindications for leukapheresis
  • Hematocrit is >33% or hemoglobin is ≥13g/dL (males) and ≥12g/dL (females) at last measurement within 7 days prior to study enrollment; test also required within 3 days prior to leukapheresis
  • Weighs more than 75 lbs
  • Not pregnant at time of enrollment
  • Ability to understand the study and must be willing to comply with study-required procedures and visits, including only changing antiretroviral regimen when indicated by the study doctor during the study period
  • Written informed consent signed and dated by study participant

Who cannot join

  • Acute or chronic hepatitis B or hepatitis C infection with detectable viremia
  • Any viral hepatitis or liver disease (e.g. cirrhosis)
  • Active or recent (prior 6 months) AIDS defining complication
  • Any experimental HIV medications within the past 12 weeks
  • Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin
  • Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias
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  • Any clinically significant renal, hepatic, and pulmonary disease
  • Inadequate venous access or contraindicated for leukapheresis
  • Significant laboratory values and/or a chronic medical condition that, in the opinion of the Principal Investigator, could impact trial participation
  • Receiving another investigational drug or device within 30 days of study entry
  • Previously received any gene transfer therapy
  • History or any features on physical examination indicative of a bleeding diathesis
  • Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g. interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to screening (NOTE: Use of inhaled or topical steroids is not exclusionary)
  • Breast-feeding or pregnant
  • Use of aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2-week period prior to leukapheresis
  • Active drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements
  • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
  • Recent vaccination or intercurrent illness within 5 weeks prior to T cell infusion (NOTE: It is recommended that participants should have completed their routine vaccinations, e.g. hepatitis A or B, pneumococcus, influenza and tetanus diphtheria booster, at least 30 days prior to screening for the study)
  • Asplenia: any conditions resulting in the absence of a functional spleen
  • History of hereditary angioedema, acquired angioedema or idiopathic angioedema

Trial locations and contacts

2 sites in 1 country.

United States2 sites, 1 recruiting

  • Institute of Human Virology, University of Maryland Baltimore

    Baltimore, Maryland, 21201

    Joyce Lam, 410-706-3367, JLam@ihv.umaryland.edu

    Jennifer Husson, MD

    Recruiting

  • Providence Hospital

    Washington D.C., District of Columbia, 20017

    Completed

Other trials in United States

About this study

Clinical specimens are required from HIV positive individuals with viremia controlled by antiretroviral therapy to complete process development for a genetically modified autologous T cell product, AGT103-T. The product will be used in a subsequent early stage clinical trial in subjects with chronic HIV disease and viremia suppressed by antiretroviral therapy as the initial step in testing a functional cure for HIV disease. Enrolled participants provide a venous blood specimen (approximately 25mL) to determine their level of HIV-reactive CD4+ T cells. Subjects with positive T cell responses will be asked to undergo leukapheresis and their clinical specimens will be used to validate and qualify the AGT103-T cell product.

Read the detailed description

This protocol is to collect blood specimens from HIV positive individuals. The first blood draw will be done at the first study visit and if eligible, the second blood collection will be done via leukapheresis at the second visit. The leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for leukapheresis.

Volunteers will be males or females between and including the ages of 18 years and 60 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 120 days (3 months).

The study will be conducted in accordance with GCP/ICH for human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a planned clinical trial.

Conditions
HIV Infections
Keywords
Volunteer, HIV, Leukapheresis
Medical subject headings
HIV Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Collection of clinical specimens

    The blood samples collected will be tested to measure the absolute and relative levels of CD4+ and CD8+ T cells. Data will describe the range of CD4+ T cell and CD8+ T cell responses to peptide stimulation. The samples will also help validate the assays and processes for the development of the cell product to be used in a future clinical trial.

    Measured: up to 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2017
  2. Study start25 Jul 2017
  3. Primary completion7 Feb 2021 (estimated)
  4. Study completion7 Feb 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03215004
Sponsor's protocol ID
AGT-CS168
Status last verified
Sep 2020
First submitted
7 Jul 2017
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by American Gene Technologies International Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collection of clinical specimens (time frame: up to 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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