Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999
Trial Information
Current as of April 26, 2025
Completed
Keywords
ClinConnect Summary
Open-label, comparative, sequentially randomized treatment with genetically unmodified or modified ex vivo-expanded T-lymphocytes in patients with HIV infection who possess a seronegative syngeneic twin. Genetic modification consists of introduction of a gene for HLA-unrestricted "universal" receptors specific for the gp120 HIV envelope protein. Treatment is divided into Periods I and II.
Gender
ALL
Eligibility criteria
- INCLUSION CRITERIA:
- • An identical twin pair, one of whom is seropositive for HIV, the other twin seronegative, by standard ELISA, PCR, and Western blot testing.
- • Patients whose CD4+ count is less than 500/mm(3) at entry must have been on FDA-approved or expanded-access antiretroviral agent(s) for at least 2 months.
- • Patients with Kaposi's sarcoma are eligible for this study, but must not have received any systemic therapy for KS within 4 weeks prior to entry. The diagnosis of KS must have been confirmed by biopsy.
- • Anticipated survival greater than 6 months and Karnofsky Performance Status greater than or equal to 60%.
- • Males or females 18 years of age or older. Every effort will be made to include both genders.
- • Free from serious psychological or emotional illness and able to provide written informed consent.
- EXCLUSION CRITERIA - RECIPIENT:
- • Lymphoma.
- • Unwillingness to comply with current NIH Clinical Center guidelines concerning appropriate notification of all current sexual partners of an individual regarding his or her HIV positive sero-status and the risk of transmission of HIV infection.
- • Recent history of substance abuse unless evidence is provided of an ongoing therapeutic intervention (i.e. medical therapy or counseling) to control such abuse.
- • Pregnancy at entry or unwillingness to practice barrier birth control or abstinence during the study.
- EXCLUSION CRITERIA - DONOR:
- • Untreated or inadequately treated medical condition (e.g., cardiopulmonary disease, acute infection) which, in the judgement of the Principal Investigator, precludes apheresis.
- • Serologic positivity for Epstein Barr virus, Cytomegalovirus, Hepatitis B or Hepatitis C if and only if the recipient twin tests seronegative for the corresponding virus.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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