Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals

• Status: Completed
• Trial end date: 2021-04-05
• Target enrollment: 0
• Participant gender: All

Summary

To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Enfuvirtide

Criteria

Inclusion Criteria:

• HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. Alternatively, two HIV-1 RNA values > 200 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent may be used to document infection.

• Patients must be ≥ 18 years of age.

• Plan to undergo a Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:

• Plan to undergo a Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:

Exclusion Criteria:

• Patients with a known history of enfuvirtide resistance will not be eligible for this trial.