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

Status unconfirmed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT03215004

Run by

American Gene Technologies International Inc.

People needed

24

Starts

2017-07-25

Expected to finish

2021-02-07

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Institute of Human Virology, University of Maryland Baltimore — Baltimore, Maryland, United States (enrolling)
• Providence Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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