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

NCT03215004 | Unknown

• 1 other identifier: AGT-CS168
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

HIV Infections

Keywords

Volunteer; HIV; Leukapheresis

Outcome Measures

Primary Outcomes (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.

  up to 120 days

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

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

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
• 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

Sponsors & Collaborators

• American Gene Technologies International Inc.: lead

Study Sites (2)

Providence Hospital

Washington D.C., District of Columbia, 20017, United States

COMPLETED

Institute of Human Virology, University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

HIV positive samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: July 25, 2017
• Primary Completion: February 7, 2021
• Study Completion: February 7, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (2)