Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation - Trial NCT04720742

Timeline & Enrollment

Primary Outcome

Time to reappearance of HIV-1 viremia,Time to reappearance of HIV-1 replication competent reservoir,Time to reappearance of HIV-1 total reservoir

Summary

The availability of antiretroviral therapy (cART) for HIV-1 infection has led to a reduction
 in morbidity in patients with chronic HIV infection. However, cART does not eliminate HIV-1
 that persists as a latent infection in cellular reservoirs. Usually, HIV viremia rapidly
 rebounds if antiretroviral therapy is interrupted. Consequently, HIV infected individuals
 must commit to expensive, life-long therapies and must tackle problems associated with
 chronic infection and uninterrupted cART, including continuous clinical and laboratory
 monitoring, drug toxicities, and chronic immune activation/inflammation.
 
 Currently, there is an emerging interest in developing safe and affordable curative
 strategies that would eliminate the need for lifelong therapy. However, to date only
 allogeneic hematopoietic stem cell transplantation (allo-HSCT) has shown results in
 decreasing the HIV-1 reservoirs.
 
 The IciStem Consortium (www.icistem.org) has assembled the largest and most exhaustive
 observational cohort for the study of HIV reservoir dynamics in allo-HSCT HIV+ individuals
 with severe hematological malignancies worldwide. Within the cohort, only individuals
 transplanted with a donor with thw CCR5A32 mutation have shown signs of HIV remission. On the
 other side broadly neutralizing antibodies (bNAbs) have shown the potential to control HIV
 infection. This study intends to evaluate if the allo-HSCT combined with the additional
 application of bNAbs is effective to control HIV replication.

ICD-10 Classifications