Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals
Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during
allogeneic hematopoietic stem cell transplant (HSCT). The primary outcome is the fraction
of patients who maintain any form of anti-retroviral therapy, including enfuvirtide
monotherapy, through day 60 post-transplant. If patients are unable to take oral
anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy
this will be considered maintenance of ART. Failure to maintain ART will be defined as ≥ 24
hours without any anti-retroviral therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT
Failure to maintain anti retroviral therapy for 24 hours
Richard Ambinder, M.D., Ph.D.
Johns Hopkins University
United States: Institutional Review Board
|The Sidney Kimmel Comprehensive Cancer Center||Baltimore, Maryland 21231|