drugset / Trial / NCT00000756

Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

NCT00000756

Open-labelTreatment

Summary

To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400; to evaluate the immunologic, virologic, and clinical changes for up to 24 weeks following infusion of study therapy. Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may help prevent HIV disease progression.

Timeline

Start
Primary completion
Completion
2002-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lymphocytes, Activated Cell therapy 1e+09 cells Other
Subject Lymphocytes, Activated Cell therapy 5e+09 cells Other
Subject Lymphocytes, Activated Cell therapy 2.5e+10 cells Other