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

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.