Status:
COMPLETED
Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Acquired Immunodeficiency Syndrome
HIV Infection
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to participate in one or more of the following new options: * Donor/recipient extension phase - Both the rec...
Detailed Description
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 tw...
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.
Key Trial Info
Start Date :
September 1 1994
Trial Type :
INTERVENTIONAL
End Date :
June 1 2002
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00001409
Start Date
September 1 1994
End Date
June 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892