Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study

Intramural NIAID sponsored several phase I-II studies of cell transfers during the 1990's, including gene-modified cells, in identical twins discordant for HIV infection. These studies were both novel in the field of alternative treatment strategies for HIV infection and served as early studies in the developing field of clinical gene therapy. The current protocol represents an umbrella protocol in which these early trials have been consolidated for purposes of long-term safety monitoring and long-term follow-up of gene-modified cell persistence. Cell recipients as well as donors enrolled in Intramural NIAID twin gene marking, gene therapy and cell transfer studies have been eligible for study participation. Participants are monitored for safety per a uniform standardized schedule. No gene therapy, cell transfers or other investigational therapeutic interventions occur under the auspices of this protocol.