A Phase 1 interventional study of Interleukin-2 in Acquired Immunodeficiency Syndrome and HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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:
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 100 is close to the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
The record gives a start of Sep 1994 and a completion of Jun 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2002. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interleukin-2
Acquired Immunodeficiency Syndrome →
National Institute of Allergy and Infectious Diseases (NIAID) →