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

NCT03215004 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2020-09-16

No results posted yet for this study

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

Sponsors & Collaborators

  • American Gene Technologies International Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2021-02-07
Completion
2021-02-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215004 on ClinicalTrials.gov