A Phase I/II Study Of the Safety, Survival, and Trafficking of Autologous CD4-ZETA Gene-Modified T Cells With and Without Extension Interleukin-2 in HIV Infected Patients

NCT01013415 Phase 1 COMPLETED

The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).

Details

Lead sponsor	University of Pennsylvania
Phase	Phase 1
Status	COMPLETED
Enrolment	17
Start date	2001-09
Completion	2021-08

Conditions

• HIV-1 Infections

Interventions

• HAART
• T cells

Primary outcomes

• Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART — Through study completion, an average of 1 year
  To assess and compare the safety of each arm when comparing related adverse events reported of subjects on study through the end of study (week 54).
• Effect of IL-2 on the Persistence of CD4-zeta T cells — Through study completion, an average of 1 year
  Subjects who received IL-2 plus gene-modified cells versus those who received cells alone will have greater numbers gene-modified cells in both PBMCs and rectal lymphoid tissue. This will be done by quantifying residual virus in the reservoir using more modern techniques that permit quantification of small amounts of virus in the rectal lymphoid tissue and to quantify specifically replication competent HIV (versus total HIV).
• To compare the viral load of subjects from baseline to the end of study. — Through study completion, an average of 1 year
  Determine the effect of CD4-zeta infusions with and without IL-2 on viral load (plasma HIV-1 RNA, tissue HIV-1 RNA, and frequency of latent replication-competent HIV-1 in PBMC) at study specific timepoints.

Countries

United States